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

Sponsor

First Affiliated Hospital of Fujian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05506566

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tumor Positron-Emission Tomography	Drug: 68Ga-FAP-CHX Drug: 68Ga-FAP-CHX	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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
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 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: 68Ga-FAPI-04 18F-FDG

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

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

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:

68Ga-FAPI-04

18F-FDG

Outcome Measures

Primary Outcome Measures

Human biodistribution [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)
Human dosimetry [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.
Standard uptake value (SUV) [Up to 2 weeks]
Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Lesion numbers [Up to 2weeks]
Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
the sensitivity of 68Ga-FAP-CHX PET/CT [Up to 2 weeks]
compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.
the specificity of 68Ga-FAP-CHX PET/CT [Up to 2 weeks]
compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.
the accuracy of 68Ga-FAP-CHX PET/CT [Up to 2 weeks]
compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.

Secondary Outcome Measures

Count of participants with treatment emergent adverse events [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
Expression ability of 68Ga-FAP-CHX in different types of tumors [Up to 3 days]
Differentiation of SUVmax in different tumors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350005

Sponsors and Collaborators

First Affiliated Hospital of Fujian Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weibing Miao, PhD, Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT05506566

Other Study ID Numbers:

FirstAHFujian-FAP-CHX

First Posted:

Aug 18, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fluorodeoxyglucose F18

Study Results

No Results Posted as of Aug 18, 2022