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Utility of Ga-68-PSMA-11 in Management of Prostate Cancer
The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.
Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Truman VA Hospital
Columbia, Missouri, United States
Start Date
July 27, 2021
Primary Completion Date
April 14, 2022
Completion Date
April 14, 2022
Last Updated
February 24, 2023
38
ACTUAL participants
Ga-68-PSMA-11
DRUG
Lead Sponsor
Timothy Hoffman
Collaborators
NCT04550494
NCT05691465
Data Source & Attribution
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