NCT07232459

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will undergo \[18F\]FT8 PET/CT scans for safety and diagnostic efficacy evaluation. Organ uptake will be quantified using the standard uptake value (SUV). Clinical assessments and laboratory tests, including baseline information collection, physical examination, cardiac function assessment, and hepatic and renal function tests, will be conducted before and after the scan.

Conditions

• Amyloid
• Cardiac Amyloidosis
• Amyloidosis
• Healthy Subjects

Interventions

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

Timeline

• Start date: 2025-07-21
• Primary completion: 2028-07-20
• Completion: 2028-12-20
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

2 sites across 1 country: China