Clinical trial

68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease

Name

FirstAHFujian7

Description

To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease

Trial arms

Trial start

2021-04-01

Estimated PCD

2024-04-01

Trial end

2024-04-01

Status

Recruiting

Phase

Early phase I

Treatment

68Ga-FAPI-04

Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.

Arms:

68Ga-FAPI-04

Size

500

Primary endpoint

Standardized uptake value (SUV)

30 days

Eligibility criteria

Inclusion Criteria: * adult patients (aged 18 years or order) * patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report) * patients who had scheduled 68Ga-FAPI-04 PET/CT scan * patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee Exclusion Criteria: * patients with pregnancy * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

Updated at

2023-09-21

1 organization

1 product

2 indications

Organization

First Affiliated Hospital of Fujian Medical University

Product

68Ga-FAPI-04

Indication

Fibrosis

Indication

Positron Emission Tomography