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

Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506566
• Other study ID #: FirstAHFujian-FAP-CHX
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Weibing Miao, MD
• Phone: 86-0591-87981618
• Email: miaoweibing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Positron-Emission Tomography
• Tumor

Intervention

Drug:
• 68Ga-FAP-CHX
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
• 68Ga-FAP-CHX
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;

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human biodistribution	reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)	From right after tracer injection to 2-hours post-injection
Primary	Human dosimetry	radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software.	From right after tracer injection to 2-hours post-injection
Primary	Standard uptake value (SUV)	Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG	Up to 2 weeks
Primary	Lesion numbers	Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG	Up to 2weeks
Primary	the sensitivity of 68Ga-FAP-CHX PET/CT	compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.	Up to 2 weeks
Primary	the specificity of 68Ga-FAP-CHX PET/CT	compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.	Up to 2 weeks
Primary	the accuracy of 68Ga-FAP-CHX PET/CT	compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.	Up to 2 weeks
Secondary	Count of participants with treatment emergent adverse events	The frequency and severity of treatment emergent adverse events following 68Ga-FAP-CHX injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0	Up to 3 days
Secondary	Expression ability of 68Ga-FAP-CHX in different types of tumors	Differentiation of SUVmax in different tumors	Up to 3 days