68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer

Early Phase 1

Recruiting

• Conditions: Tumor
• Interventions: Drug: 68Ga-FAPI-Biotin; Drug: 68Ga-FAPI/18F-FDG

• Registration Number: NCT06740240
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

As a new dual targeting PET radiotracer, 68Ga-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 68Ga-FAPI-Biotin in patients with various types of cancer and compared them with the results of 68Ga-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-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. 68Ga-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAPI-Biotin, and performed a head-to-head comparison with 68Ga-FAPI or 18F-FDG PET/CT scans in patients with various cancers.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-Biotin PET/ CT	68Ga-FAPI-Biotin	Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI-Biotin. Tracer of 68Ga-FAPI-Biotin will be used to detect tumors by PET/CT.
68Ga-FAPI/18F-FDG PET/CT	68Ga-FAPI/18F-FDG	Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg18F-FDG. Tracer of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.

Primary Outcome Measures

Name	Time	Method
Diagnostic value	through study completion, an average of 3 months.	Sensitivity and Specificity of 68Ga-FAPI-Biotin in Patients With Various Types of Cancer and compare it with 68Ga-FAPI/18F-FDG PET/CT.

Secondary Outcome Measures

Name	Time	Method
SUV of tumors	through study completion, an average of 3 months.	Compare the SUV of tumors between 68Ga-FAPI-Biotin PET/CT and 68Ga-FAPI/18F-FDG PET/CT.

Trial Locations

Locations (1)

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, China