Positron-Emission Tomography, Tumor
Conditions
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.
Interventions
DRUG68Ga-FAP-CHX
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression ability of 68Ga-FAP-CHX in different types of tumors | Up to 3 days | Differentiation of SUVmax in different tumors |
| 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 |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactJie Zang, MD
Outcome results
None listed