NCT06387381 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
| NCT ID | NCT06387381 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | First Affiliated Hospital of Chongqing Medical University |
| Condition | PSMA |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-05-20 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06387381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PSMA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06387381 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06387381 currently recruiting?
Yes, NCT06387381 is actively recruiting participants. Contact the research team at zhangxy@mail.bnu.edu.cn for enrollment information.
Where is the NCT06387381 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06387381 clinical trial?
NCT06387381 is sponsored by First Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 30 participants.