68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Chongqing Medical University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-PSFA
DrugEach subject receives a single intravenous injection of 68Ga-PSFA.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: 68Ga-PSFAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic efficacy
The sensitivity, specificity, and accuracy of 68Ga-PSFA PET
Time frame
15 daysSponsors and contacts
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Source ClinicalTrials.gov