Status:

RECRUITING

68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

Lead Sponsor:

First Affiliated Hospital of Fujian Medical University

Conditions:

Prostate Cancer (Adenocarcinoma)

Eligibility:

MALE

18-80 years

Phase:

PHASE1

PHASE2

Brief Summary

68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-n...

Detailed Description

68Ga-P16-093 is a novel radiotracer targeting PSMA. Previously, we conducted multiple studies confirming the clinical application of 68Ga-P16-093 PET/CT. However, multi-parametric magnetic resonance i...

Eligibility Criteria

Inclusion

  • Biopsy-confirmed adenocarcinoma of the prostate.
  • No anti-tumor treatment received prior to the PET imaging.
  • Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
  • Radical prostatectomy scheduled within 28 days after PET imaging.

Exclusion

  • Patients with other malignant tumors
  • Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Key Trial Info

Start Date :

October 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07209865

Start Date

October 1 2024

End Date

June 30 2026

Last Update

October 7 2025

Active Locations (1)

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1

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350005