Preclinical evaluation and first-in-human study of 68Ga- and Al18F-Labeled PSMA/FAP bispecific tracers for prostate cancer imaging.
Xinlin Wang, Ming Wang, Yimin Chen...
https://pubmed.ncbi.nlm.nih.gov/41120594Actively Recruiting
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06690970
Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
Led by Tianjin Medical University · Updated on 2025-08-11
500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tianjin Medical University
Lead Sponsor
T
Tianjin Medical University General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the usefulness of 68Ga/18F-PSMA/PSFA positron emission tomography/computed tomography (PET/CT) imaging for diagnosing primary and metastatic lesions in patients with various PSMA-related diseases, including prostate cancer. This observational study aims to assess how well this imaging method detects malignant tumors and metastases by measuring uptake values and diagnostic accuracy. Each participant receives a single intravenous injection of the imaging agent 68Ga/18F-PSMA/PSFA, followed by a PET/CT scan within a specified time. This procedure is performed once per participant, focusing on both initial assessment and recurrence detection of tumors. Participants undergo the PET/CT imaging procedure and provide consent before enrollment. Researchers measure the maximum standardized uptake value (SUVmax) from the scans and evaluate diagnostic performance, including sensitivity and specificity. The primary outcome is the SUV measured within 30 days, with diagnostic efficacy also assessed within the same timeframe. The total study duration extends until 2027, with safety and accuracy monitored throughout.
CONDITIONS
Brief Title
Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Patients with suspected, newly diagnosed, or previously treated malignant tumors supported by MRI, CT, tumor markers, or pathology
- Patients scheduled for PSMA PET/CT scan
- Patients able to provide informed consent and assent as required by ethics guidelines
You will not qualify if you...
- Patients with non-malignant lesions
- Pregnant patients
- Patients unable or unwilling to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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 - Single day
Participants receive a single intravenous injection of 68Ga/18F-PSMA/PSFA and undergo PET/CT imaging for assessment of PSMA-related disease.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 30 days
Participants are observed for up to 30 days after imaging to assess diagnostic efficacy and standardized uptake values.
Follow-up as needed
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230000
Actively Recruiting
2
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
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Research Team
H
Haonan Yu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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