RecruitingPhase 1Phase 2NCT07056790

Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

40 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • confirmed treated or untreated prostate cancer patients;
  • signed written consent.

Exclusion Criteria2

  • known allergy against PSMA;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Interventions

DRUG68Ga-PSMA-CYC

Each prostate cancer patient underwent a 68Ga-PSMA-CYC (3-4 mCi) PET/CT scan, as well as a 68Ga-PSMA-617 (3-4 mCi) or 68Ga-PSMA-11 (3-4 mCi) PET/CT scan, with the time interval between the two scans not exceeding one week.

DRUGCYC

The dose will be 3-4mCi given intravenously.


Locations(1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT07056790


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