Status:
COMPLETED
Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
Lead Sponsor:
Norbert Avril, M.D.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for characterization of prostate abnormaliti...
Detailed Description
Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored...
Eligibility Criteria
Inclusion
- Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
- Able to tolerate PET/CT scans
- Informed consent must be given and signed
Exclusion
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- Known allergy against Ga-68 PSMA
- Prior prostate biopsy within the last 2 weeks
Key Trial Info
Start Date :
June 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04867603
Start Date
June 29 2021
End Date
October 3 2022
Last Update
December 19 2023
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065