A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer

Part of paid clinical trials in Irvine, California.

Sponsor
Hoag Memorial Hospital Presbyterian
Study ID
NCT06736054
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copper 61-PSMA PET/CT — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 14, 2024
Status verified
Oct 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT
    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.

Primary Outcome Measure

Incidence of Imaging Agent-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 24 hours after administration of radiotracer ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianIrvineCalifornia92616
Gary A Ulaner, MD, PhD
[email protected]
949-557-0285
Beth Thomsen, CNMT
[email protected]
949-557-0285

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By research site
Hoag Memorial Hospital Presbyterian· Irvine, CA

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