NCT06387381
Recruiting
Early Phase 1
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
First Affiliated Hospital of Chongqing Medical University1 site in 1 country30 target enrollmentMay 20, 2024
Overview
- Phase
- Early Phase 1
- Intervention
- 68Ga-PSFA
- Conditions
- PSMA
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Diagnostic efficacy
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases.
Investigators
Xiaoyang Zhang
Principal Investigator
First Affiliated Hospital of Chongqing Medical University
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age.
- •Signed informed consent.
- •Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).
Exclusion Criteria
- •Patients with non-malignant disease.
- •Patients with pregnancy.
- •The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
- •Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Arms & Interventions
68Ga-PSFA
Patients will receive a single administration of 68Ga-PSFA.
Intervention: 68Ga-PSFA
Outcomes
Primary Outcomes
Diagnostic efficacy
Time Frame: 15 days
The sensitivity, specificity, and accuracy of 68Ga-PSFA PET
Study Sites (1)
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