What is 68Ga-PSFA studying for PSMA/FAP positive diseases?

68Ga-PSFA is being studied as a new imaging agent to detect lesions in diseases that show PSMA or FAP markers. Researchers want to understand how well this PET tracer works and if it is safe to use. The study is sponsored by the First Affiliated Hospital of Chongqing Medical University.

Who may be eligible for this PSMA/FAP positive disease clinical trial?

Adults 18 years and older with suspected or confirmed PSMA or FAP positive disease may be eligible. The trial is open to all genders and requires that participants can provide informed consent. People who are pregnant, have non-malignant disease, or have allergies to 68Ga-PSFA are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this PSMA/FAP positive disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect no charges for study procedures.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

Healthy Volunteers

ID06387381

68Ga-PSFA PET Imaging in Patients With PSMAFAP Positive Disease

Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-06-04

Participants Needed

Research Sites

87 weeks

Total Duration

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

Research Team

Xiaoyang Zhang, PhD

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