68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease

NCT06387381 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Chongqing Medical University

Phase

Phase EARLY_PHASE1

Started

2024-05-20

Last updated

2025-06-04

Condition(s) studied

PSMAFAPPositron-Emission Tomography

Investigational drug(s) / intervention(s)

68Ga-PSFA

68Ga-PSFA: Each subject receives a single intravenous injection of 68Ga-PSFA.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: 1. At least 18 years of age. 2. Signed informed consent. 3. 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: 1. Patients with non-malignant disease. 2. Patients with pregnancy. 3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. 4. Known or expected hypersensitivity to 68Ga-PSFA or any of its components. 5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Primary outcome measure(s)

Diagnostic efficacy — 15 days
The sensitivity, specificity, and accuracy of 68Ga-PSFA PET

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06387381 on ClinicalTrials.gov ↗ ← All trials in China