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Clinical Trial NCT06387381 for PSMA, FAP, Positron-Emission Tomography is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease Early Phase 1 30

Recruiting
Clinical Trial NCT06387381 is designed to study Diagnostic for PSMA, FAP, Positron-Emission Tomography. It is a Early Phase 1 interventional study that is recruiting, having started on 20 May 2024, with plans to enroll 30 participants. Led by First Affiliated Hospital of Chongqing Medical University, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 4 June 2025.
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.
Official Title

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

Conditions
PSMAFAPPositron-Emission Tomography
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • CYYY-KY-2024-048-01
NCT ID Number
NCT06387381
Start Date (Actual)
2024-05-20
Last Update Posted
2025-06-04
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental68Ga-PSFA
Patients will receive a single administration of 68Ga-PSFA.
68Ga-PSFA
Each subject receives a single intravenous injection of 68Ga-PSFA.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnostic efficacy
The sensitivity, specificity, and accuracy of 68Ga-PSFA PET
15 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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).

  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.
First Affiliated Hospital of Chongqing Medical University logoFirst Affiliated Hospital of Chongqing Medical University
Study Responsible Party
Xiaoyang Zhang, Principal Investigator, Principal Investigator, First Affiliated Hospital of Chongqing Medical University
Study Central Contact
Contact: Xiaoyang Zhang, PhD, 86 023-89011755, [email protected]
1 Study Locations in 1 Countries

Chongqing Municipality

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400016, China
Xiaoyang Zhang, PhD, Contact, 023-89011755, [email protected]
Recruiting