RecruitingNCT07232459

[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis

Clinical Study of [18F]FT8 PET/CT in Evaluating Amyloidosis


Sponsor

Tianjin Medical University

Enrollment

25 participants

Start Date

Jul 21, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

\[18F\]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene (\[18F\]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish \[18F\]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of \[18F\]FT8 PET imaging in human subjects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET scan imaging agent called [18F]FT8 to see if it can better detect amyloidosis in the heart — a condition where abnormal proteins build up in heart tissue and affect its function. The goal is to improve diagnosis using advanced imaging. **You may be eligible if...** - You are 18 years or older - You are suspected of having, newly diagnosed with, or previously diagnosed with cardiac amyloidosis - Supporting evidence includes cardiac MRI, CT scan, or blood biomarkers suggesting amyloidosis - You are either a patient at the Hematology Department of Tianjin Medical University General Hospital, or a healthy volunteer **You may NOT be eligible if...** - You have severe kidney disease or allergies to contrast agents - You are unable to undergo PET/CT imaging - You are pregnant or breastfeeding - You have a pacemaker or other implant that interferes with imaging - You are not able to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST[18F]FT8

Each subject will receive a single intravenous injection of \[18F\]FT8 and will undergo PET imaging at a specified time.


Locations(2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

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NCT07232459


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