Advanced 18F-fluoride PET Imaging to Improve Diagnosis and Treatment Monitoring in Cardiac Transthyretin Amyloidosis

What this Trial Is About

Researchers are studying transthyretin amyloid cardiomyopathy ATTR-CM, a heart muscle disease that impairs heart function and is becoming more common with age. Untreated, ATTR-CM has a poor outlook. This observational study aims to improve monitoring of novel, costly treatments by using a new imaging technique called 18F-fluoride PET. This could help understand why some patients respond to treatment while others do not, and improve care for those affected. The study evaluates 18F-fluoride PET imaging to better detect and measure calcium deposits in the heart muscle caused by ATTR-CM. The study includes multiple work packages optimizing imaging protocols, differentiating ATTR-CM from similar conditions, calibrating imaging against current standards, and tracking disease progression and response to tafamidis treatment over time. Participants will undergo PET scans and other assessments to gather detailed imaging data. Participants will be monitored for up to 2.5 years with imaging, cardiac magnetic resonance, biomarker tests, and clinical evaluations. Researchers will measure myocardial tissue-to-background ratio TBR thresholds and changes to track disease status and treatment effects. The study includes safety monitoring and aims to reduce patient burden by designing procedures carefully. Total participation spans from initial imaging to one-year follow-up and beyond.

Quantitative-imaging in Cardiac Transthyretin Amyloidosis