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

This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 4) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET/MRI). In a subgroup of patients who are unable to undergo PET/MR, computed tomography will be used instead of MRI (i.e. PET/CT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.

NCT Number	NCT05758493
Lead Sponsor	Oregon Health and Science University Collaborators: Attralus, Inc., Bayer
Conditions	Amyloidosis, Transthyretin Amyloidosis
Enrollment	150 participants
Start Date	2023-01-10
Primary Completion	2027-12-10 (estimated)
Study Completion	2028-03-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-13