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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
MALE
ID05324332

A Pilot Comparison of 68Ga-P16-093 and 68Ga-PSMA-11 PETCT Imaging in Primary Prostate Cancer Patients

Led by Peking Union Medical College Hospital · Updated on 2025-09-22

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Prostate cancer is a common cancer among men with high mortality rates. Detecting prostate tumors and metastases accurately is important but challenging with certain imaging methods like 18F-FDG PETCT. This research evaluates a new imaging agent called 68Ga-P16-093, which targets prostate-specific membrane antigen PSMA and aims to compare its diagnostic ability with the well-studied 68Ga-PSMA-11 in the same group of patients with primary prostate cancer. Participants receive two whole-body PETCT scans on consecutive days. Each scan involves an intravenous injection of either 68Ga-P16-093 or 68Ga-PSMA-11 at a dose of 1.8-2.2 MBq per kilogram of body weight. These radiopharmaceuticals are used to image prostate cancer lesions by targeting PSMA, which is overexpressed on prostate cancer cells. The study is a pilot comparison designed to assess and compare the performance of these two tracers. During the study, researchers measure the tumor detection rate and standardized uptake value SUV of tumors for up to one year. Participants undergo imaging procedures and provide informed consent before enrollment. The study monitors diagnostic accuracy and tracer uptake to evaluate the potential of the new agent. The total involvement includes PETCT scans on two separate days and follow-up assessments to review the imaging results.

CONDITIONS

Brief Title

68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients

Who Can Participate

Age: 18Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed untreated primary prostate cancer
  • Undergo both 68Ga-PSMA-11 and 68Ga-P16-093 PET/CT scans within one week
  • Signed written consent to participate
Not Eligible

You will not qualify if you...

  • Known allergy to prostate-specific membrane antigen (PSMA)
  • Any medical condition that may significantly interfere with study participation according to the investigator

Research Team

Z

Zhaohui Zhu, MD

G

Guochang Wang, MD

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