Clinical trial

68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies in Cancer Patients

Name

FirstAHFujian-FAP-RGD

Description

As an new dual targeting PET radiotracer, 68Ga-FAP-RGD is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.

Trial arms

Trial start

2022-05-01

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Recruiting

Phase

Early phase I

Treatment

68Ga-FAP-RGD

The dose will be 4-7mCi given intravenously.

Arms:

Part I: safety, tolerability, biodistribution and dosimetry

68Ga-FAP-RGD

68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) given intravenously at a single time prior to imaging. 68Ga-FAPI-02, the dose will be 1.8 (MBq /kg) given intravenously at a single time prior to imaging; 18F-FDG, the dose will be 3.7 (MBq / kg) given intravenously at a single time prior to imaging.

Arms:

Part II: diagnostic efficacy

Size

Primary endpoint

Human biodistribution

From right after tracer injection to 2-hours post-injection

Human dosimetry

From right after tracer injection to 2-hours post-injection

Standard uptake value (SUV)

Up to 2 weeks

Lesion numbers

Up to 2 weeks

the sensitivity of 68Ga-FAP-RGD PET/CT

Up to 2 weeks

the specificity of 68Ga-FAP-RGD PET/CT

Up to 2 weeks

the accuracy of 68Ga-FAP-RGD PET/CT

Up to 2 weeks

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': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-09-21

1 organization

1 product

1 indication

Organization

First Affiliated Hospital of Fujian Medical University

Product

68Ga-FAP-RGD

Indication

Tumor