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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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PSMA FAP Positron-Emission Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-PSFA

Patients will receive a single administration of 68Ga-PSFA.

Group Type EXPERIMENTAL

68Ga-PSFA

Intervention Type DRUG

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

Interventions

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68Ga-PSFA

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes