Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
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|ClinicalTrials.gov Identifier: NCT03353740|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ga-68 labeled PSMA-11 PET||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Drug: Ga-68 labeled PSMA-11 PET
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
- Sensitivity on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. [ Time Frame: 12 months ]Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.
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): NCT03353740
|United States, California|
|UCSF Imaging Center at China Basin||Recruiting|
|San Francisco, California, United States, 94107|
|Contact: Raven Smith 415-353-9448 firstname.lastname@example.org|
|Principal Investigator: Thomas Hope, MD|
|Principal Investigator:||Thomans Hope, MD||University of California, San Francisco|