Clinical Trial · NCT04867603

Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions

Overview

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 abnormalities.

Sponsor

Case Comprehensive Cancer Center

Contacts

Norbert Avril, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04867603

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

Able to tolerate PET/CT scans
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.

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