68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Tumor; Positron-Emission Tomography

Treatments: Drug: 68Ga-FAP-CHX

Study type: Interventional

Funder types: Other

Identifiers

NCT05506566

FirstAHFujian-FAP-CHX

Details and patient eligibility

About

As an emerging molecule targeting FAP, 68Ga-FAP-CHX 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-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.

Full description

Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years < Age < 75 years
• Various solid tumors with available histopathological findings, and have not been treated surgically.
• Signed informed consent.

Exclusion criteria

• patients with pregnancy
• the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Part I: safety, tolerability, biodistribution and dosimetry

Experimental group

Description:

PET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes

Treatment:

Drug: 68Ga-FAP-CHX

Drug: 68Ga-FAP-CHX

Part II: diagnostic efficacy

Experimental group

Description:

Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG).

Treatment:

Drug: 68Ga-FAP-CHX

Drug: 68Ga-FAP-CHX