- Recruiting
- Diagnostic
- Interventional
- Drug
- PHASE1
- Hoag Memorial Hospital Presbyterian
- 18 Years -
Study Purpose
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.
Intervention
Drug : Copper 61-PSMA PET/CT
Eligibility Requirements
Biopsy proven prostate adenocarcinoma
Age ≥ 18 years
ECOG 0 or 1
At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.
Known allergy/hypersensitivity to PSMA-targeted imaging agents
Other active malignancy, other than the known prostate cancer
Recruiting status
Recruiting
Estimated enrollment
8
Study start date
Oct 14, 2024
Study end date
Mar 31, 2025
Last updated
Mar 24, 2025
Primary purpose
Diagnostic
Design
Interventional
Intervention
Drug
Study phase
PHASE1
Allocation
Na
Sponsor:
Hoag Memorial Hospital Presbyterian
Collaborator:
N/A
Investigator:
N/A
NCT06736054
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