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RECRUITING
NCT05758493
PHASE2

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

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

Summary

This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1)identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 2) 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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-01-10

Completion Date

2028-03-10

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

124I-Evuzamitide

Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States