Recruiting
Phase 1

61Cu-NODAGA-PSMA

Sponsor:

Hoag Memorial Hospital Presbyterian

Code:

NCT06736054

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Copper 61-PSMA PET/CT

Study Details

Brief 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.

Conditions

Prostate Adenocarcinoma

Study ID

NCT06736054

Start date

Oct 14, 2024

Status verified date

Oct, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Biopsy proven prostate adenocarcinoma
2. Age ≥ 18 years
3. ECOG 0 or 1
4. At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.

Exclusion Criteria:

1. Known allergy/hypersensitivity to PSMA-targeted imaging agents
2. Other active malignancy, other than the known prostate cancer

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Copper 61-PSMA 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 ]

Central Contacts and Locations

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Irvine, California, United States, 92616

Contacts

Gary A Ulaner, MD, PhD

949-557-0285gary.ulaner@hoag.org

Beth Thomsen, CNMT

949-557-0285beth.thomsen@hoag.org

More Information

Sponsor

Hoag Memorial Hospital Presbyterian

Last update posted

Dec 16, 2024

Last verified

Oct, 2024

Keywords

  • PSMA
  • PET/CT
  • Phase 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hoag Memorial Hospital Presbyterian on 2024-12-16.