[68Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [68Ga]Ga-PSMA-11.
Jiarou Wang, Linlin Li, Jingci Chen...
https://pubmed.ncbi.nlm.nih.gov/41366119Actively Recruiting
Phase Not Applicable
Age: 18Years - 90Years
MALE
ID05324332
A Pilot Comparison of 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT 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 PET/CT. 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 PET/CT 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 PET/CT 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
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 2 days
Participants undergo two whole-body PET/CT scans on consecutive days after intravenous injection of tracer doses of 68Ga-P16-093 and 68Ga-PSMA-11 to image prostate cancer lesions.
2 visits (in-person) on consecutive days
Long-term Monitoring
Duration - Up to 1 year
Participants are monitored for tumor detection rate and standardized uptake value (SUV) of tumor for up to 1 year after imaging.
Visit schedule varies; assessments conducted through study completion
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
Z
Zhaohui Zhu, MD
G
Guochang Wang, MD
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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Published Research Related To This Trial
A prospective head-to-head comparison of [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT in patients with primary prostate cancer.
Guochang Wang, Linlin Li, Ming Zhu...
https://pubmed.ncbi.nlm.nih.gov/37233785