68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04216134|
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Biochemically Recurrent Prostate Carcinoma||Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography||Phase 1|
I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial.
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes.
After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer|
|Actual Study Start Date :||December 12, 2019|
|Estimated Primary Completion Date :||December 20, 2020|
|Estimated Study Completion Date :||December 20, 2020|
Experimental: Diagnostic (68GA-PSMA-11 PET)
Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes.
Drug: Gallium Ga 68-labeled PSMA-11
Procedure: Positron Emission Tomography
Undergo 68GA-PSMA-11 PET
- Incidence of adverse events [ Time Frame: Up to 3 months ]Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216134
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Ammar Chaudhry 626-218-6442 firstname.lastname@example.org|
|Principal Investigator: Ammar Chaudhry|
|Principal Investigator:||Ammar Chaudhry||City of Hope Medical Center|