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

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.

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Key information

Conditions

PSMA FAP Positron-Emission Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Xiaoyang Zhang, PhD

CONTACT

[email protected]

023-89011755

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

At least 18 years of age.
Signed informed consent.
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

Patients with non-malignant disease.
Patients with pregnancy.
The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Treatment and study plan

68Ga-PSFA

Drug

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

Primary outcomes

Diagnostic efficacy

Time frame: 15 days

The sensitivity, specificity, and accuracy of 68Ga-PSFA PET

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyang Zhang, PhD

CONTACT

[email protected]

86 023-89011755

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Apr 29, 2024
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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