Clinical trial

68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers

Name

FirstAHFujian-68Ga-FAPI-JH04

Description

68Ga-FAPI-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH040182 in patients with different types of cancer.

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-06-10

Trial end

2024-07-01

Status

Recruiting

Phase

Early phase I

Treatment

68Ga-FAPI-JH04

The dose will be 148-222 MBq given intravenously.

Arms:

dynamic PET scans

Size

Primary endpoint

safety and tolerability

Up to 1 week

Eligibility criteria

Inclusion Criteria: * Various solid tumors with available histopathological findings * Signed informed consent Exclusion Criteria: * pregnant or lactational women * who suffered from severe hepatic and renal insufficiency

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Drug: 68Ga-FAPI-JH04', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ESTIMATED'}}

Updated at

2024-05-31

1 organization

1 product

1 indication

Organization

First Affiliated Hospital of Fujian Medical University

Product

68Ga-FAPI-JH04

Indication

Cancer