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Clinical Trials in China / NCT06734572
Recruiting Early Phase 1

18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study

NCT06734572 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Fujian Medical University
Phase
Early Phase 1
Started
2024-06-25
Last updated
2024-12-16

Condition(s) studied

Malignant Neoplasm

Investigational drug(s) / intervention(s)

18F-FAPIBiotin

18F-FAPIBiotin: The dose will be 148-296 MBq given intravenously.

Study summary

As a new dual targeting PET radiotracer, 18F-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 18F-FAPI-Biotin in patients with various types of cancer and compared them with the results of 18F-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 18F-FAPI.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)

  • Dosimetry of normal organs and tumors — From right after tracer injection to 120 minutes at post-injection
    The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 18F-FAPI-Biotin. The dose delivered to normal organs and tumors will be recorded.

Trial sites (1)

FacilityCityRegionStatus
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Recruiting

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Other trials for the same condition

68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study Recruiting
68Ga-FAPI PET/CT in Malignant Tumors Recruiting
NV-001 in the Treatment of Advanced Solid Tumors Recruiting
68Ga-NI-FAPI PET/CT: First-in-human Study Recruiting
Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors Recruiting
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 NCT06734572 on ClinicalTrials.gov ↗ ← All trials in China