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

Positron-Emission Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387381
• Other study ID #: CYYY-KY-2024-048-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 20, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Xiaoyang Zhang, PhD
• Phone: 86 023-89011755
• Email: zhangxy[@]mail.bnu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• FAP
• Positron-Emission Tomography

Intervention

Drug:
• 68Ga-PSFA
Each subject receives a single intravenous injection of 68Ga-PSFA.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficacy	The sensitivity, specificity, and accuracy of 68Ga-PSFA PET	15 days