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NCT Number: NCT06740240

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

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.

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Key information

Conditions

Tumor Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location status: Recruiting

Location contact

Weibing Miao, MD

CONTACT

[email protected]

+86-0591-87981618

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-FAPI-Biotin

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

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.

Primary outcomes

  1. Diagnostic value

    Time frame: 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 outcomes

  1. SUV of tumors

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Lin, MD

CONTACT

[email protected]

+86-0591-87981619

Weibing Miao, MD

CONTACT

[email protected]

+86-0591-87981618

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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