Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07232459

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

Led by Tianjin Medical University · Updated on 2025-11-18

25

Participants Needed

2

Research Sites

178 weeks

Total Duration

On this page

Sponsors

T

Tianjin Medical University

Lead Sponsor

T

Tianjin Medical University General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

\[18F\]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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis supported by cardiac MRI, contrast-enhanced CT, serum biomarkers, or histopathology
  • Scheduled for a clinical Pan-Amyloid PET/CT scan as part of standard care or evaluation
  • Able to understand study procedures and provide written informed consent
  • Healthy volunteers aged 18 years or older with no active cardiac or systemic disease confirmed by medical history, physical exam, and ECG
  • Healthy volunteers able to understand study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Confirmed non-cardiac amyloidosis or other non-amyloid cardiac diseases affecting image interpretation
  • Pregnancy or breastfeeding
  • Any medical, psychological, or social condition that may impair participation or study completion
  • History or current diagnosis of significant cardiac, hepatic, renal, or neurological disorders (for healthy volunteers)
  • Any condition increasing risk or interfering with study data interpretation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

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

Hefei, Anhui, China, 230000

Actively Recruiting

2

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China, 350005

Actively Recruiting

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Research Team

H

Haonan Yu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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