Recruiting NCT06387381
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-PSFA.
- Who it may be relevant to
- Registry conditions: PSMA, FAP, Positron-Emission Tomography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 68Ga-PSFA
Each subject receives a single intravenous injection of 68Ga-PSFA.
Primary outcome measures
- Diagnostic efficacy [Time frame: 15 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
Publications
- Wang X, Zhang X, Zhang X, Guan L, Gao X, Xu L, Pang H, Du J, Zhang J, Cui M. Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer. Eur J Nucl Med Mol Imaging. 2025 Feb;52(3):1166-1176. doi: 10.1007/s00259-024-06965-7. Epub 2024 Nov 9. PMID 39520516
Identifiers
NCT: NCT06387381 · CYYY-KY-2024-048-01