68Ga-P16-093 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Contact Information
Primary
Weibing Miao, MD
miaoweibing@126.com
86-0591-87981618
Backup
Guochang Wang, MD
guochang1007@163.com
86-0591-87981619
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 50
Treatments
Experimental: 68Ga-P16-093 PET/CT
Intravenous injection of 68Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Fujian Medical University