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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06387381
Other study ID # CYYY-KY-2024-048-01
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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