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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: safety, tolerability, biodistribution and dosimetry | Experimental | 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 |
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| Part II: diagnostic efficacy | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAP-CHX | Drug | The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Miao, MD | Contact | 86-0591-87981618 | miaoweibing@126.com | |
| Jie Zang, MD | Contact | 15901495106 | 15901495106@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weibing Miao, MD | The First Affiliated Hospital, Fujian Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707753 | 68Ga-FAPI |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| 68Ga-FAP-CHX | Drug | 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； |
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| Up to 2 weeks |
| Expression ability of 68Ga-FAP-CHX in different types of tumors |
Differentiation of SUVmax in different tumors |
| Up to 3 days |