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

Chongqing Medical University

Status and phase: Enrolling; Early Phase 1

Conditions: FAP; PSMA; Positron-Emission Tomography

Treatments: Drug: 68Ga-PSFA

Study type: Interventional

Funder types: Other

Identifiers

NCT06387381

CYYY-KY-2024-048-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

68Ga-PSFA

Experimental group

Description:

Patients will receive a single administration of 68Ga-PSFA.

Treatment:

Drug: 68Ga-PSFA