Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer.
Xinlin Wang, Xiaoyang Zhang, Xiaojun Zhang...
https://pubmed.ncbi.nlm.nih.gov/39520516Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID06387381
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-06-04
30
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new imaging agent called 68Ga-PSFA, which targets two receptors, PSMA and FAP, to improve the diagnosis of diseases that express these markers. This early phase 1 trial aims to evaluate the safety, distribution in the body, and diagnostic potential of this PET radiotracer for detecting lesions in patients with PSMA or FAP positive diseases. Participants will receive a single intravenous injection of 68Ga-PSFA. This administration is designed to allow imaging of disease sites expressing the PSMA or FAP markers. No placebo or comparison group is involved, and the study focuses on one treatment arm where all patients receive the investigational imaging agent. During the study, participants will be monitored for diagnostic effectiveness within 15 days after injection. Researchers will assess how well the agent detects lesions and track any side effects or safety concerns. The trial is open to adults aged 18 and older who meet certain disease criteria and consent to participate, with no maximum age limit specified.
CONDITIONS
Brief Title
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Signed informed consent
- Patients with suspected or newly diagnosed or previously malignant disease, showing PSMA or FAP positive expression supported by MRI, CT, pathology, or other evidence
You will not qualify if you...
- Patients with non-malignant disease
- Pregnant patients
- Inability or unwillingness to provide written informed consent
- Known or expected hypersensitivity to 68Ga-PSFA or its components
- Any serious medical condition or circumstance that may interfere with study procedures or evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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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 - Single day
Participants receive a single intravenous injection of 68Ga-PSFA for PET imaging to assess PSMA/FAP positive disease.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
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Research Team
X
Xiaoyang Zhang, PhD
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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