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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
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• Subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance

• Patient willing to consent for the study and undergo the study procedures.

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Ahmad Masri, MD
masria@ohsu.edu
503-418-1964
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2028-03-10
Participants
Target number of participants: 150
Treatments
Experimental: Patients with ATTR-CM
Patients with ATTR-CM will undergo hybrid 124I-Evuzamitide PET/MRI imaging (or PET/CT) at baseline and in a subgroup, repeat imaging will be performed at an interval of 6-12 months.
Sponsors
Collaborators: Attralus, Inc.
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov