68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
- Registration Number
- NCT05506566
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 18 years < Age < 75 years
- Various solid tumors with available histopathological findings, and have not been treated surgically.
- Signed informed consent.
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part I: safety, tolerability, biodistribution and dosimetry 68Ga-FAP-CHX 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 Part II: diagnostic efficacy 68Ga-FAP-CHX 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).
- Primary Outcome Measures
Name Time Method 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.
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
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.
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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China