Trial Outcomes & Findings for GA-68 DOTA-TOC of Somatostatin Positive Malignancies (NCT NCT02177773)
NCT ID: NCT02177773
Last Updated: 2019-11-12
Results Overview
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT
TERMINATED
PHASE1/PHASE2
300 participants
1 day
2019-11-12
Participant Flow
Participant milestones
| Measure |
DOTATOC Imaging
All patients received a single DOTATOC imaging study.
|
|---|---|
|
Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
300
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GA-68 DOTA-TOC of Somatostatin Positive Malignancies
Baseline characteristics by cohort
| Measure |
Ga-68 DOTA-TOC PET/CT
n=300 Participants
Patients receive gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.
Computed Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT
Gallium Ga 68-Edotreotide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo gallium Ga 68-DOTA-TOC PET/MRI
Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT
Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/MRI
|
|---|---|
|
Age, Customized
10-19 years
|
2 Participants
n=39 Participants
|
|
Age, Customized
20-29 years
|
6 Participants
n=39 Participants
|
|
Age, Customized
30-39 years
|
22 Participants
n=39 Participants
|
|
Age, Customized
40-49 years
|
38 Participants
n=39 Participants
|
|
Age, Customized
50-59 years
|
71 Participants
n=39 Participants
|
|
Age, Customized
60-69 years
|
106 Participants
n=39 Participants
|
|
Age, Customized
70-79 years
|
48 Participants
n=39 Participants
|
|
Age, Customized
80-89 years
|
7 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
226 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
46 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
201 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
69 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
300 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 dayPopulation: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 dayPopulation: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.
Outcome measures
Outcome data not reported
Adverse Events
DOTATOC Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas Hope, MD
Unviersity of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place