This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.
PRIMARY OBJECTIVES: Evaluate the feasibility and biodistribution of 68Ga-PSMA. OUTLINE: Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later. After completion of study, patients are followed up at 24 hours and 1 week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Part of PET/CT scan
Intravenously-administered (IV) radioisotope
Part of PET/MRI scan
Stanford University, School of Medicine
Palo Alto, California, United States
Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.
Time frame: an estimated average of 1 hour
Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.
Time frame: an estimated average of 1 hour
Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)
Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
Time frame: an estimated average of 1 hour
Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)
Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
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Part of PET/CT and/or PET/MRI scans
Time frame: an estimated average of 1 hour
Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan
Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.
Time frame: an estimated average of 2 hours