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

NCT ID: NCT06734572

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-12-31

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.

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

dynamic PET scans

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

Group Type: EXPERIMENTAL

18F-FAPIBiotin

Intervention Type: DRUG

The dose will be 148-296 MBq given intravenously.

Interventions

18F-FAPIBiotin

The dose will be 148-296 MBq given intravenously.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weibing Miao, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weibing Miao, MD

Role: CONTACT

miaoweibing@126.com

+86-0591-87981618

Rong Lin, MD

Role: CONTACT

linrong1214@foxmail.com

+86-0591-87981619

Facility Contacts

Weibing Miao, MD

Role: primary

miaoweibing@126.com

+86-0591 87981618

Chao Wang, MD

Role: backup

mauiijc4761lw@163.com

+86-0591 87981619

Other Identifiers

FirstAHFujian-18F-FAPIBiotin

Identifier Type: -

Identifier Source: org_study_id