At a glance
ClinicalIndex Comparison Record- ✓Biopsy-proven prostate adenocarcinoma
- ✓Age 18 years or older
- ✓At least one site of PSMA-positive disease on PSMA-targeted PET/CT within 30 days of enrollment
- ✕Known allergy or hypersensitivity to PSMA-targeted imaging agents
- ✕Other active malignancy besides prostate cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06736054Phase 1RecruitingUpdate OverdueUpdated 18mo ago · Completion was 15mo agoA Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
In Brief
A Phase 1 clinical trial evaluating Copper 61-PSMA PET/CT for Prostate Adenocarcinoma. Currently recruiting, targeting 8 participants across 1 site.
Signals
Detailed Summary
Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production. This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.
Study Details
Timeline
Interventions
TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.