SUV on PSMA PET/CT in Non-Prostate Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03841760|
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2019
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Diagnostic Test: PSMA PET/CT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SUV on PSMA PET/CT in Non-Prostate Tumors|
|Actual Study Start Date :||July 25, 2019|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||June 2025|
Experimental: PSMA PET/CT
One (1) PSMA PET/CT scan with with either PSMA-11 or DCFPyL
Diagnostic Test: PSMA PET/CT
For 18F-DCFPyL PET/CT: Approximately 9 mCi (333MBq) of 18F-DCFPyL is injected intravenously. Approximately 60-90 minutes following 18F-DCFPyL injection, CT and PET images are consecutively acquired from the base of the skull to the toes.
For 68Ga-PSMA-11 PET/CT: Approximately 2.5 MBq/kg (0.068 mCi/kg) of 68Ga-PSMA, up to a maximum of 300 MBq (8 mCi), is injected intravenously. Approximately 60 minutes following 68Ga-PSMA injection, CT and PET images are consecutively acquired from the base of the skull to toes.
Other Name: PSMA PET
- Confirm PSMA PET uptake in tumors studied [ Time Frame: Immediate ]1. To confirm 18F-DCFPyL PET/CT or 68Ga-PSMA-11 uptake in the known tumor or other lesions found on PSMA PET/CT. The threshold for a positive lesion is a semi-quantitative measurement of activity: SUVmax > 4 in lesions larger than 1.5 cm (so as to offset PET partial volume effect or "camera limitations"). IF SUVmax > 4, the tumor is positive for PSMA PET/CT; If not, the tumor is negative for PSMA PET/CT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841760
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T1E2|