Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06736054

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

Led by Hoag Memorial Hospital Presbyterian · Updated on 2024-12-16

8

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven prostate adenocarcinoma
  • Age 18 years or older
  • ECOG performance status of 0 or 1
  • At least one PSMA-positive disease site on PSMA-targeted PET/CT within 30 days prior to enrollment
  • Creatinine level of 1.4 or less or creatinine clearance of 60 mL/min or higher
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to PSMA-targeted imaging agents
  • Presence of another active cancer besides known prostate cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hoag Memorial Hospital Presbyterian

Irvine, California, United States, 92616

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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