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

F

Fujian Medical University (FJMU)

Status and phase

Enrolling
Early Phase 1

Conditions

Tumor

Treatments

Drug: 68Ga-FAPI/18F-FDG
Drug: 68Ga-FAPI-Biotin

Study type

Interventional

Funder types

Other

Identifiers

NCT06740240
FirstAHFujian-FAPI-Biotin

Details and patient eligibility

About

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.

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. 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 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

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

68Ga-FAPI-Biotin PET/ CT
Experimental group
Description:
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.
Treatment:
Drug: 68Ga-FAPI-Biotin
68Ga-FAPI/18F-FDG PET/CT
Active Comparator group
Description:
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.
Treatment:
Drug: 68Ga-FAPI/18F-FDG

Trial contacts and locations

1

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Central trial contact

Rong Lin, MD; Weibing Miao, MD

Data sourced from clinicaltrials.gov

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