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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
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；
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGHuman 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)
Time frame: 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.
Time frame: 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
Time frame: Up to 2 weeks
Lesion numbers
Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 weeks
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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
Time frame: Up to 3 days
Expression ability of 68Ga-FAP-CHX in different types of tumors
Differentiation of SUVmax in different tumors
Time frame: Up to 3 days