Studying Iodine-124 Evuzumitide Imaging for Diagnosis and Organ Analysis in Adults with Systemic and Transthyretin Amyloidosis

What this Trial Is About

Researchers are evaluating the use of 124I-evuzumitide as an imaging agent to study systemic amyloidosis, including transthyretin amyloid cardiomyopathy ATTR-CM. This phase 2 study aims to establish how accurately 124I-evuzumitide detects cardiac amyloidosis, examine its uptake outside the heart, and understand its distribution in affected organs. The study also analyzes how this uptake relates to the structure and function of these organs, using clinical data such as demographics, imaging, and laboratory results to better characterize the disease. Participants with ATTR-CM will undergo hybrid positron emission tomography combined with magnetic resonance imaging PETMRI or computed tomography PETCT if MRI is not possible. Imaging will be performed at the start of the study, with some participants having repeat scans 6 to 12 months later. The study involves a single intravenous administration of 124I-evuzumitide as the diagnostic agent. During the study, participants will have imaging assessments and collection of clinical data including cardiac biomarkers and questionnaires related to heart function. Researchers will measure diagnostic accuracy, quantitative imaging metrics, and correlations between imaging results and clinical symptoms or disease stage. Safety of the imaging agent will be monitored for seven days after administration. The total participation period includes baseline and possible follow-up imaging up to 12 months later.

Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis