Actively Recruiting
68Ga-P16-093 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-10-07
50
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 68Ga-P16-093, a new radiotracer targeting PSMA, in PET imaging for diagnosing newly diagnosed, untreated prostate cancer. This study aims to compare the diagnostic accuracy of 68Ga-P16-093 PET imaging (using PET/CT or PET/MRI) directly against multi-parameter magnetic resonance imaging (mpMRI), which is currently a leading method. The study is conducted by the First Affiliated Hospital of Fujian Medical University and includes patients with biopsy-confirmed prostate adenocarcinoma who have not started treatment. Participants will receive an intravenous injection of 68Ga-P16-093 at a dose of 111-148 MBq (3-4 mCi), followed by either PET/CT or PET/MRI scans using standard techniques. The imaging will be conducted before the patient undergoes radical prostatectomy, which is scheduled within 28 days of the PET scan. This allows a head-to-head comparison of the new PET imaging method with mpMRI to assess detection rates of intraprostatic tumors. During the study, patients will undergo whole-body PET scans about 1-2 hours after dosing with 68Ga-P16-093. Researchers will evaluate how sensitive and specific 68Ga-P16-093 PET imaging is for detecting prostate tumors by comparing imaging results to histopathology from the prostatectomy specimens. The primary outcomes include sensitivity and specificity of the PET imaging. The study participation involves imaging procedures and surgery within a defined timeframe, with outcomes assessed by comparing imaging to tissue analysis.
CONDITIONS
Brief Title
68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 to 2 hours on the imaging day
Participants receive an intravenous injection of 68Ga-P16-093 followed by PET/CT or PET/MRI imaging to assess prostate cancer, compared head-to-head with mpMRI.
1 imaging visit (in-person)
Duration - Up to 28 days after imaging
Participants undergo radical prostatectomy within 28 days following the imaging to confirm diagnosis and evaluate imaging results.
1 surgical visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, 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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