What is 18F-FAPI-Biotin studying for cancer?

18F-FAPI-Biotin is being studied as a new imaging tracer that targets specific proteins in cancer to improve detection. Researchers want to understand how it distributes in the body and how much radiation it delivers compared to other tracers. This trial is sponsored by the First Affiliated Hospital of Fujian Medical University.

Who may be eligible for this malignant neoplasm clinical trial?

Adults aged 18 to 80 with various solid tumors confirmed by tissue analysis may be eligible. The trial is open to all genders but excludes pregnant or breastfeeding women and those with severe liver or kidney problems. Please review eligibility criteria for more details.

Is there any cost to participate in this malignant neoplasm clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Early Phase 1

Age: 18Years - 80Years

All Genders

ID06734572

18F-FAPIBiotin PETCT Dosimetry and Biodistribution Study in Patients With Various Cancers

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-12-16

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new dual targeting PET radiotracer called 18F-FAPI-Biotin in patients with various types of cancer. This tracer aims to improve tumor detection by targeting both fibroblast activation protein, which is highly expressed in many cancer stromas, and biotin, which is overexpressed in tumor cells but underexpressed in normal cells. The study focuses on assessing the safety, how the tracer distributes in the body, and the radiation dosimetry compared to existing tracers like 18F-FAPI and 18F-FDG. Participants receive an intravenous dose of 148-296 MBq of 18F-FAPI-Biotin. PET imaging is conducted dynamically at multiple time points 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 120 minutes after injection. This allows researchers to observe the tracers pharmacokinetics and dosimetry across different organs and tumors. The study is classified as an early phase 1 trial. During the study, patients undergo PETCT scans at the specified time points following tracer injection. Researchers monitor the dosimetry of normal organs and tumors from immediately after injection up to 120 minutes later. Safety assessments include tracking adverse events for up to one week using standard criteria. The total participation duration includes imaging sessions and safety monitoring to evaluate the tracers distribution and potential side effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Various solid tumors with available histopathological findings
Signed informed consent
Age between 18 and 80 years

You will not qualify if you...

Pregnant or lactational women
Severe hepatic and renal insufficiency

Research Team

Weibing Miao, MD

Rong Lin, MD

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