68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | June 2015 |
| End Date: | August 2016 |
68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
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.
(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.
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.
Inclusion Criteria:
- Provides written informed consent
- Known diagnosis of prostate cancer
- Patient has suspected recurrence based on biochemical data (prostate specific antigen
[PSA] > 2 ng/mL)
- Able to remain still for duration of each imaging procedure (about one hour)
Exclusion Criteria:
- Unable to provide informed consent
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating
circumstance that, in the opinion of the Investigator, may significantly interfere
with study compliance
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