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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tumor, Positron-Emission Tomography

Intervention / Treatment
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* Drug: 68Ga-FAP-CHX
* Drug: 68Ga-FAP-CHX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I: safety, tolerability, biodistribution and dosimetry<br>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<br>* The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging<br>|
| Experimental: Part II: diagnostic efficacy<br>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<br>* 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；<br>* Other names: 18F-FDG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Lesion numbers | 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 | 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 | 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 | 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 | 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 | Differentiation of SUVmax in different tumors | Up to 3 days |