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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06387381
Enrollment
30
Registered
2024-04-29
Start date
2024-05-20
Completion date
2026-12-31
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FAP, Positron-Emission Tomography, PSMA

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.

Interventions

DRUG68Ga-PSFA

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

Sponsors

First Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic efficacy15 daysThe sensitivity, specificity, and accuracy of 68Ga-PSFA PET

Countries

China

Contacts

Primary ContactXiaoyang Zhang, PhD
zhangxy@mail.bnu.edu.cn86 023-89011755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026