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

NCT ID: NCT05506566

Condition: Tumor
Positron-Emission Tomography

Conditions: Official terms:
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68Ga-FAP-CHX
Description: The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
Arm group label: Part I: safety, tolerability, biodistribution and dosimetry

Intervention type: Drug
Intervention name: 68Ga-FAP-CHX
Description: 68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging; 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging; 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging;
Arm group label: Part II: diagnostic efficacy

Other name: 68Ga-FAPI-04

Other name: 18F-FDG

Summary: 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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Address:
City: Fuzhou
Zip: 350005
Country: China

Status: Recruiting

Contact:
Last name: Weibing Miao, MD

Phone: 059187981618
Email: miaoweibing@126.com

Contact backup:
Last name: Jie Zang, MD

Phone: 15901495106
Email: 15901495106@163.com

Start date: May 1, 2022

Completion date: May 1, 2025

Lead sponsor:
Agency: First Affiliated Hospital of Fujian Medical University
Agency class: Other

Source: First Affiliated Hospital of Fujian Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05506566

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