18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-FAPIBiotin.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasm. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
Overview
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
- Drug 18F-FAPIBiotin
The dose will be 148-296 MBq given intravenously.
Primary outcome measures
- Dosimetry of normal organs and tumors [Time frame: From right after tracer injection to 120 minutes at post-injection]
Secondary outcome measures (1)
- Incidence of Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0. [Time frame: up to 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT06734572 · FirstAHFujian-18F-FAPIBiotin