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Clinical Trials/NCT06387381
NCT06387381
Recruiting
Early Phase 1

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

First Affiliated Hospital of Chongqing Medical University1 site in 1 country30 target enrollmentMay 20, 2024

Overview

Phase
Early Phase 1
Intervention
68Ga-PSFA
Conditions
PSMA
Sponsor
First Affiliated Hospital of Chongqing Medical University
Enrollment
30
Locations
1
Primary Endpoint
Diagnostic efficacy
Status
Recruiting
Last Updated
11 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 20, 2024
End Date
December 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Xiaoyang Zhang

Principal Investigator

First Affiliated Hospital of Chongqing Medical University

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.

Arms & Interventions

68Ga-PSFA

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

Intervention: 68Ga-PSFA

Outcomes

Primary Outcomes

Diagnostic efficacy

Time Frame: 15 days

The sensitivity, specificity, and accuracy of 68Ga-PSFA PET

Study Sites (1)

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