Trial Outcomes & Findings for A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan (NCT NCT06240741)
NCT ID: NCT06240741
Last Updated: 2026-02-03
Results Overview
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). * TP participants were those who showed at least one lesion based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FN participants were those who did not show any lesions based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
COMPLETED
PHASE3
71 participants
Day 1
2026-02-03
Participant Flow
This study was not designed to compare efficacy between NEN patients and HVs, but rather to assess sensitivity and specificity of Ga-DOTA-TATE PET/CT imaging against the CIM in the population which includes both of CIM positive and negative.
Therefore, efficacy results related to the diagnostic performance are presented as a single combined population of NEN patients and HVs. Baseline characteristics, other efficacy (e.g. number of lesions), safety, and PK results are presented separately due to the differences between the NEN patient and HV populations. These approaches are as per the protocol and the statistical analysis plan.
Participant milestones
| Measure |
[68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
23
|
|
Overall Study
COMPLETED
|
48
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
Baseline characteristics by cohort
| Measure |
[68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs
n=48 Participants
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
n=23 Participants
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=41 Participants
|
23 Participants
n=1581 Participants
|
71 Participants
n=4626 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=41 Participants
|
22 Participants
n=1581 Participants
|
51 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
33 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=41 Participants
|
13 Participants
n=1581 Participants
|
38 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM positive participants (TP or FN participants).
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). * TP participants were those who showed at least one lesion based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FN participants were those who did not show any lesions based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
Outcome measures
| Measure |
All Participants
n=46 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants)
True Positive [TP]
|
40 Participants
|
—
|
|
Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants)
False Negative [FN]
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM negative participants (TN or FP participants).
Subject-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). * TN participants were those who did not show any lesions based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FP participants were those who showed at least one lesion based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but did not show any lesions based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
Outcome measures
| Measure |
All Participants
n=25 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants)
True Negative [TN]
|
23 Participants
|
—
|
|
Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants)
False Positive [FP]
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM positive participants (TP or FN participants).
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\] Sensitivity = TP / (TP + FN)
Outcome measures
| Measure |
All Participants
n=46 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Subject-level Sensitivity
|
87.0 Sensitivity (%)
Interval 73.74 to 95.06
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM negative participants (TN or FP participants).
Subject-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\] Specificity = TN / (TN + FP).
Outcome measures
| Measure |
All Participants
n=25 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Subject-level Specificity
|
92.0 Specificity (%)
Interval 73.97 to 99.02
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are positive on \[68Ga\]Ga-DOTA TATE PET/CT imaging (TP or FP participants).
Subject-level positive predictive values (PPV) is defined as the proportion of TP participants among \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants).
Outcome measures
| Measure |
All Participants
n=42 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Number of Participants Who Are Positive on Both [68Ga]Ga-DOTA-TATE PET/CT Imagings and CIM (TP Participants) Among Participants Who Are Positive on [68Ga]Ga-DOTA TATE PET/CT Imaging (TP or FP Participants)
True Positive [TP]
|
40 Participants
|
—
|
|
Number of Participants Who Are Positive on Both [68Ga]Ga-DOTA-TATE PET/CT Imagings and CIM (TP Participants) Among Participants Who Are Positive on [68Ga]Ga-DOTA TATE PET/CT Imaging (TP or FP Participants)
False Positive [FP]
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are negative on \[68Ga\]Ga-DOTA-TATE PET/CT imaging (TN or FN participants).
Subject-level NPV was defined as the proportion of TN participants among \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants).
Outcome measures
| Measure |
All Participants
n=29 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Number of Participants Who Are Negative on Both [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM (TN Participants) Among Participants Who Are Negative on [68Ga]Ga-DOTA-TATE PET/CT Imaging (TN or FN Participants)
False Negative [FN]
|
6 Participants
|
—
|
|
Number of Participants Who Are Negative on Both [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM (TN Participants) Among Participants Who Are Negative on [68Ga]Ga-DOTA-TATE PET/CT Imaging (TN or FN Participants)
True Negative [TN]
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants).
Subject-level positive predictive values (PPV) is defined as the proportion of TP participants among \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants). PPV (Subject-level positive predictive values) = TP / (TP + FP)
Outcome measures
| Measure |
All Participants
n=42 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Subject-level PPV
|
95.2 PPV (%)
Interval 83.84 to 99.42
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants).
Subject-level NPV was defined as the proportion of TN participants among \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants). NPV (Subject-level negative predictive values) = TN / (TN + FN)
Outcome measures
| Measure |
All Participants
n=29 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Subject-level NPV
|
79.3 NPV (%)
Interval 60.28 to 92.01
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Subject-level accuracy is defined as the proportion of TP and TN participants among all patients in the EFF (i.e. TP+TN+FP+FN participants). Accuracy = (TP + TN) / (TP + TN + FP + FN).
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Participants Who Have Consistent Results (i.e. TP or TN Participants) Among All Participants Assessed by [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM - Subject-level Accuracy
|
88.7 Accuracy (%)
Interval 79.0 to 95.01
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Region-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive regions (TP regions) among CIM positive regions (i.e. TP or FN regions). Sensitivity = TP / (TP + FN)
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level Sensitivity
Other
|
84.6 Sensitivity (%)
Interval 54.55 to 98.08
|
—
|
|
Region-level Sensitivity
Liver
|
77.8 Sensitivity (%)
Interval 60.85 to 89.88
|
—
|
|
Region-level Sensitivity
Pancreas
|
42.9 Sensitivity (%)
Interval 17.66 to 71.14
|
—
|
|
Region-level Sensitivity
Gastrointestinal tract
|
0 Sensitivity (%)
Interval 0.0 to 97.5
|
—
|
|
Region-level Sensitivity
Lymph nodes
|
75.0 Sensitivity (%)
Interval 47.62 to 92.73
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Region-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative regions (TN regions) among CIM negative regions (i.e. TN or FP regions). Specificity = TN / (TN + FP) Note: Even when a participant is categorized as positive in subject-level, he/she can still have negative results in region-level. e.g. When only Liver is positive and other regions are negative, the participant is categorized as positive in subject-level. As all participants had at least one CIM-negative region and were included in the table, the number of participants analyzed is 71.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level Specificity
Liver
|
97.1 Specificity(%)
Interval 85.08 to 99.93
|
—
|
|
Region-level Specificity
Pancreas
|
89.5 Specificity(%)
Interval 78.48 to 96.04
|
—
|
|
Region-level Specificity
Gastrointestinal tract
|
95.7 Specificity(%)
Interval 87.98 to 99.11
|
—
|
|
Region-level Specificity
Lymph nodes
|
83.6 Specificity(%)
Interval 71.2 to 92.23
|
—
|
|
Region-level Specificity
Other
|
94.8 Specificity(%)
Interval 85.62 to 98.92
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Region-level PPV is defined as the proportion of regions which are positive on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM (TP regions) among \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive regions (i.e. TP or FP regions). Region-level positive predictive values (PPV) = TP / (TP +FP)
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level Positive Predictive Values (PPV)
Liver
|
96.6 PPV (%)
Interval 82.24 to 99.91
|
—
|
|
Region-level Positive Predictive Values (PPV)
Pancreas
|
50.0 PPV (%)
Interval 21.09 to 78.91
|
—
|
|
Region-level Positive Predictive Values (PPV)
Gastrointestinal tract
|
0 PPV (%)
Interval 0.0 to 70.76
|
—
|
|
Region-level Positive Predictive Values (PPV)
Lymph nodes
|
57.1 PPV (%)
Interval 34.02 to 78.18
|
—
|
|
Region-level Positive Predictive Values (PPV)
Other
|
78.6 PPV (%)
Interval 49.2 to 95.34
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Region-level NPV is defined as the proportion of regions which are negative on both \[68Ga\]Ga- DOTA-TATE PET/CT imaging and CIM (TN regions) among \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative regions (i.e. TN or FN regions). Region-level negative predictive values (NPV) = TN / (TN + FN) Note: Even when a participant is categorized as positive in subject-level, he/she can still have negative results in region-level. e.g. When only Liver is positive and other regions are negative, the participants is categorized as positive in subject-level. As all participants had at least one negative region by Ga-DOTA-TATE PET/CT and were included in the table, the number of participants analyzed = 71.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level Negative Predictive Values (NPV)
Liver
|
81.0 NPV (%)
Interval 65.88 to 91.4
|
—
|
|
Region-level Negative Predictive Values (NPV)
Pancreas
|
86.4 NPV (%)
Interval 75.02 to 93.96
|
—
|
|
Region-level Negative Predictive Values (NPV)
Gastrointestinal tract
|
98.5 NPV (%)
Interval 92.08 to 99.96
|
—
|
|
Region-level Negative Predictive Values (NPV)
Lymph nodes
|
92.0 NPV (%)
Interval 80.77 to 97.78
|
—
|
|
Region-level Negative Predictive Values (NPV)
Other
|
96.5 NPV (%)
Interval 87.89 to 99.57
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Region-level accuracy is defined as the proportion of regions which are CIM and \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive (TP regions) or negative (TN regions) among regions detected by CIM and \[68Ga\]Ga-DOTA-TATE PET/CT imaging (i.e. TP+TN+FP+FN regions). Accuracy = (TP + TN) / (TP + TN + FP + FN).
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level Accuracy
Liver
|
87.3 accuracy (%)
Interval 77.3 to 94.04
|
—
|
|
Region-level Accuracy
Pancreas
|
80.3 accuracy (%)
Interval 69.14 to 88.78
|
—
|
|
Region-level Accuracy
Gastrointestinal tract
|
94.4 accuracy (%)
Interval 86.2 to 98.44
|
—
|
|
Region-level Accuracy
Lymph nodes
|
81.7 accuracy (%)
Interval 70.73 to 89.87
|
—
|
|
Region-level Accuracy
Other
|
93.0 accuracy (%)
Interval 84.33 to 97.67
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
TP regions were the regions which showed at least one lesion based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level True Positive
Liver
|
28 Participants
|
—
|
|
Region-level True Positive
Pancreas
|
6 Participants
|
—
|
|
Region-level True Positive
Gastrointestinal tract
|
0 Participants
|
—
|
|
Region-level True Positive
Lymph nodes
|
12 Participants
|
—
|
|
Region-level True Positive
Other
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
FN regions were the regions which did not show any lesions based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but show at least one lesion based on CIM by central read.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level False Negative
Gastrointestinal tract
|
1 Participants
|
—
|
|
Region-level False Negative
Pancreas
|
8 Participants
|
—
|
|
Region-level False Negative
Lymph nodes
|
4 Participants
|
—
|
|
Region-level False Negative
Other
|
2 Participants
|
—
|
|
Region-level False Negative
Liver
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
FP regions were the regions which showed at least one lesion based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but do not showed any lesion based on CIM by central read.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level False Positive
Liver
|
1 Participants
|
—
|
|
Region-level False Positive
Pancreas
|
6 Participants
|
—
|
|
Region-level False Positive
Gastrointestinal tract
|
3 Participants
|
—
|
|
Region-level False Positive
Lymph nodes
|
9 Participants
|
—
|
|
Region-level False Positive
Other
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
TN regions were the regions which did not show any lesion based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Region-level True Negative
Liver
|
34 Participants
|
—
|
|
Region-level True Negative
Pancreas
|
51 Participants
|
—
|
|
Region-level True Negative
Gastrointestinal tract
|
67 Participants
|
—
|
|
Region-level True Negative
Lymph nodes
|
46 Participants
|
—
|
|
Region-level True Negative
Other
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: Before and after imaging on Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM, with a valid measurement without a protocol deviation with impact. Patients with confirmed/suspected NENs)
Numbers of participants for each intended treatment plan collected from physician at pre and post \[68Ga\]Ga-DOTA-TATE PET/CT imaging will be summarized.
Outcome measures
| Measure |
All Participants
n=48 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Observation/surveillance Before - Observation/surveillance After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Chemotherapy - Before imaging
|
8 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Lutathera - Before imaging
|
14 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Observation/surveillance - Before imaging
|
6 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Radiation - Before imaging
|
0 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Somatostatin Analog - Before imaging
|
15 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Surgery - Before imaging
|
5 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Other - Before imaging
|
2 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Chemotherapy - After imaging
|
6 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Lutathera - After imaging
|
17 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Observation/surveillance - After imaging
|
7 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Radiation - After imaging
|
2 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Somatostatin Analog - After imaging
|
15 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Surgery - After imaging
|
4 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Planned treatment of Other - After imaging
|
2 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Participants with no change in treatment plans - After imaging
|
30 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Chemotherapy - After imaging
|
4 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Chemotherapy, Somatostatin Analog - After imaging
|
2 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Lutathera -After imaging
|
10 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
-Observation/surveillance -After imaging
|
3 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Somatostatin Analog -After imaging
|
8 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Surgery -After imaging
|
2 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Other -After imaging
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
Participants with change in treatment plans
|
18 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
-Chemotherapy Before - Lutathera After
|
2 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
-Lutathera Before - Lutathera, Radiation After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Lutathera Before - Lutathera, Surgery After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
-Lutathera Before - Observation/surveillance After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Lutathera Before - Radiation After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Observation/surveillance Before - Lutathera After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Observation/surveillance Before - Somatostatin Analog After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Somatostatin Analog Before - Lutathera After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Somatostatin Analog Before - Observation/surveillance After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Somatostatin Analog Before - Somatostatin Analog After
|
3 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Surgery Before - Lutathera, Surgery After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
-Surgery Before - Observation/surveillance After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Surgery Before - Somatostatin Analog After
|
1 Participants
|
—
|
|
Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires
- Other Before - Other After
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
The assessment of \[68Ga\]Ga-DOTA-TATE PET/CT images set was compared among the 3 independent readers.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Central Reader 1 Positive
|
54 Participants
|
—
|
|
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Central Reader 2 Positive
|
42 Participants
|
—
|
|
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Central Reader 3 Positive
|
41 Participants
|
—
|
|
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Central Reader 1 Negative
|
17 Participants
|
—
|
|
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Central Reader 2 Negative
|
29 Participants
|
—
|
|
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Central Reader 3 Negative
|
30 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
Inter-reader variability for \[68Ga\]Ga-DOTA-TATE PET/CT imaging is defined as agreement rate among reader determinations. As assessed by Fleiss' Kappa statistics. Inter-reader variability (%) and its normality 95% CI is presented.
Outcome measures
| Measure |
All Participants
n=71 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Inter-reader Variability (%) on [68Ga]Ga-DOTA-TATE PET/CT Imaging
|
65.2 Inter-reader variability (%)
Interval 51.79 to 78.65
|
—
|
SECONDARY outcome
Timeframe: For treated pts: AEs are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days. For HV pts: AEs are reported from the study start plus 8 days, up to a maximum timeframe of 9 days.Population: The Safety Set comprised all participants who received any dose of \[68Ga\]Ga-DOTA-TATE.
An adverse event (AE) is any untoward medical occurrence (e.g., any occurrence of unfavorable and unintended sign(s), symptom(s) or medical condition, including abnormal laboratory findings, or worsening of any pre-existing sign(s), symptom(s) or medical condition) in a participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of any treatment used in this study. This includes events reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative).
Outcome measures
| Measure |
All Participants
n=48 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
n=23 Participants
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Adverse events (AEs)
|
8 Participants
|
2 Participants
|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Adverse events - Treatment-related
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Serious Adverse events (SAEs)
|
2 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Serious Adverse events Treatment-related
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Fatal SAEs
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Fatal SAEs - Treatment-related
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
AEs requiring additional therapy
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-inf) will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
0.420 h*ng/mL
Geometric Coefficient of Variation 25.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUClast will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
0.304 h*ng/mL
Geometric Coefficient of Variation 26.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
0.656 ng/mL
Geometric Coefficient of Variation 30.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
0.0750 hour
Interval 0.0333 to 0.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Terminal Elimination Half-life (T1/2) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
1.77 hour
Geometric Coefficient of Variation 26.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Total Systemic Clearance for Intravenous Administration (CL) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
26.0 L/h
Geometric Coefficient of Variation 32.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)Population: PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Vz will be listed and summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=6 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
|
66.2 L
Geometric Coefficient of Variation 53.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 30Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
The lesion-level concordance rate for SSTR between \[68Ga\]Ga-DOTA-TATE PET/CT imaging local read and local histopathology result among legions which is available, will be calculated. The rate is defined as the proportion of lesions which are positive or negative on both local read of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and local histopathology among lesions detected by local histopathology.
Outcome measures
| Measure |
All Participants
n=48 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
+ Result of SSTR by histopathology & -Result of [68Ga]Ga-DOTA-TATE PET/CT imaging by local read
|
0 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
Negative Result of [68Ga]Ga-DOTA-TATE PET/CT imaging by local read
|
0 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
Total number of lesions with histopathology assessments
|
11 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
Positive Result of SSTR by histopathology
|
8 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
Negative Result of SSTR by histopathology
|
3 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
Positive Result of [68Ga]Ga-DOTA-TATE PET/CT imaging by local read
|
11 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
+ Result of SSTR by histopathology - + Result of [68Ga]Ga-DOTA-TATE PET/CT imaging by local read
|
8 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
- Result of SSTR by histopathology & + Result of [68Ga]Ga-DOTA-TATE PET/CT imaging by local read
|
3 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
- Result of SSTR by histopathology & - Result of [68Ga]Ga-DOTA-TATE PET/CT imaging by local read
|
0 lesions
|
—
|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available
Lesions with concordant results
|
8 lesions
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 30Population: The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with \[68Ga\]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of \[68Ga\]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact.
The lesion-level concordance rate for SSTR between \[68Ga\]Ga-DOTA-TATE PET/CT imaging local read and local histopathology result among legions which is available, will be calculated. The rate is defined as the proportion of lesions which are positive or negative on both local read of \[68Ga\]Ga-DOTA-TATE PET/CT imaging and local histopathology among lesions detected by local histopathology.
Outcome measures
| Measure |
All Participants
n=48 Participants
Confirmed/suspected NENs + HVs. All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available - Concordance Rate
|
72.7 Concordance rate (%)
Interval 39.03 to 93.98
|
—
|
Adverse Events
[68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs
Healthy Volunteers
Serious adverse events
| Measure |
[68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs
n=48 participants at risk
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
n=23 participants at risk
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
Other adverse events
| Measure |
[68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs
n=48 participants at risk
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
Healthy Volunteers
n=23 participants at risk
All eligible participants received \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
|
|---|---|---|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
Platelet count decreased
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
Electrocardiogram PR prolongation
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
General disorders
Malaise
|
0.00%
0/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
4.3%
1/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
General disorders
Pyrexia
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Hepatobiliary disorders
Liver disorder
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
White blood cell count decreased
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Investigations
White blood cells urine positive
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
0.00%
0/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/48 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
4.3%
1/23 • Adverse events are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER