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

NCT ID: NCT06740240

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-FAPI-Biotin PET/ CT

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.

Group Type EXPERIMENTAL

68Ga-FAPI-Biotin

Intervention Type DRUG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI-Biotin. Tracer doses of 68Ga-FAPI-Biotin will be used to detect tumors by PET/CT

68Ga-FAPI/18F-FDG PET/CT

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.

Group Type ACTIVE_COMPARATOR

68Ga-FAPI/18F-FDG

Intervention Type DRUG

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

Interventions

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68Ga-FAPI-Biotin

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI-Biotin. Tracer doses of 68Ga-FAPI-Biotin will be used to detect tumors by PET/CT

Intervention Type DRUG

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)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.

Intervention Type DRUG

Eligibility Criteria

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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

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weibing Miao, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

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First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao, MD

Role: CONTACT

Phone: +86-0591-87981618

Email: [email protected]

Rong Lin, MD

Role: CONTACT

Phone: +86-0591-87981619

Email: [email protected]

Facility Contacts

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Weibing Miao, MD

Role: primary

Other Identifiers

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FirstAHFujian-FAPI-Biotin

Identifier Type: -

Identifier Source: org_study_id