Trial Outcomes & Findings for Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI (NCT NCT03404648)
NCT ID: NCT03404648
Last Updated: 2021-02-08
Results Overview
Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
Baseline
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
High Risk Prostate Cancer Patients
Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).
C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
|
|---|---|
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Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Risk Prostate Cancer Patients
n=19 Participants
Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).
C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
|
|---|---|
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Age, Continuous
|
63.9 years
STANDARD_DEVIATION 6.0 • n=19 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: BaselineMeasured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.
Outcome measures
| Measure |
High Risk Prostate Cancer Patients
n=19 Participants
Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).
C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
|
|---|---|
|
Uptake Value of C11-choline
|
6.2 Ratio
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: BaselineMeasured by the mean number of lesions to show C11-Choline uptake.
Outcome measures
| Measure |
High Risk Prostate Cancer Patients
n=19 Participants
Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).
C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
|
|---|---|
|
Number of Lesions Showing C11-Choline Uptake
|
1.2 Lesions
Standard Deviation 0.4
|
Adverse Events
High Risk Prostate Cancer Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place