Malignant Neoplasm
Conditions
Brief summary
As a new dual targeting PET radiotracer, 18F-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 18F-FAPI-Biotin in patients with various types of cancer and compared them with the results of 18F-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 18F-FAPI.
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. Biotin is overexpressed in various tumor cells and underexpressed in normal cells. We assume that expanding molecular probes targeting FAPI and biotin with dual targets to enhance the targeting ability of the tracer, improve the sensitivity and specificity of tumor lesion detection. 18F-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 18F-FAPI-Biotin, and performed a head-to-head comparison with 18F-FAPI or 18F-FDG PET/CT scans in patients with various cancers.
Interventions
DRUG18F-FAPIBiotin
The dose will be 148-296 MBq given intravenously.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Various solid tumors with available histopathological findings • Signed informed consent
Exclusion criteria
* pregnant or lactational women • who suffered from severe hepatic and renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry of normal organs and tumors | From right after tracer injection to 120 minutes at post-injection | The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 18F-FAPI-Biotin. The dose delivered to normal organs and tumors will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0. | up to 1 week | safety and tolerability |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactRong Lin, MD
Outcome results
None listed