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

September 16, 2023 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part I: safety, tolerability, biodistribution and dosimetry
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
Drug: 68Ga-FAP-CHX
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
Drug: 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；
Other Names:
  • 18F-FDG
  • 68Ga-FAPI-04
Experimental: Part II: diagnostic efficacy
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).
Drug: 68Ga-FAP-CHX
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
Drug: 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；
Other Names:
  • 18F-FDG
  • 68Ga-FAPI-04

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human biodistribution
Time Frame: From right after tracer injection to 2-hours post-injection
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
Human dosimetry
Time Frame: From right after tracer injection to 2-hours post-injection
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
Standard uptake value (SUV)
Time Frame: Up to 2 weeks
Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Up to 2 weeks
Lesion numbers
Time Frame: Up to 2weeks
Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Up to 2weeks
the sensitivity of 68Ga-FAP-CHX PET/CT
Time Frame: Up to 2 weeks
compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.
Up to 2 weeks
the specificity of 68Ga-FAP-CHX PET/CT
Time Frame: Up to 2 weeks
compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.
Up to 2 weeks
the accuracy of 68Ga-FAP-CHX PET/CT
Time Frame: Up to 2 weeks
compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.
Up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of participants with treatment emergent adverse events
Time Frame: Up to 3 days
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
Expression ability of 68Ga-FAP-CHX in different types of tumors
Time Frame: Up to 3 days
Differentiation of SUVmax in different tumors
Up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Investigators

  • Study Chair: Weibing Miao, MD, the First Affiliated Hospital, Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstAHFujian-FAP-CHX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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