Actively Recruiting
[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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
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
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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