18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: 18F-FAPIBiotin

Study type: Interventional

Funder types: Other

Identifiers

NCT06734572

FirstAHFujian-18F-FAPIBiotin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

dynamic PET scans

Experimental group

Description:

PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 120 minutes after injection.

Treatment:

Drug: 18F-FAPIBiotin