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

NCT06740240 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Phase EARLY_PHASE1

Started

2024-03-01

Last updated

2024-12-18

Condition(s) studied

Tumor

Investigational drug(s) / intervention(s)

68Ga-FAPI-Biotin68Ga-FAPI/18F-FDG

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

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
First Affiliated Hospital of Fujian Medical University	Fuzhou	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740240 on ClinicalTrials.gov ↗ ← All trials in China