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

NCT07209865 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-07

No results posted yet for this study

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-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).

Conditions

  • Prostate Cancer (Adenocarcinoma)

Interventions

DRUG

68Ga-P16-093

Intravenous injection of Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods.

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Weibing Miao, MD · First Affiliated Hospital of Fujian Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209865 on ClinicalTrials.gov