Actively Recruiting
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Led by Oregon Health and Science University · Updated on 2026-04-13
150
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
A
Attralus, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 90 years
- Have systemic amyloidosis with known organ involvement, or carry a known pathogenic mutation in the transthyretin gene, or have multiple myeloma, or monoclonal gammopathy of undetermined significance
- Willing to consent to the study and undergo study procedures
You will not qualify if you...
- Severe claustrophobia or any medical condition preventing completion of imaging
- Known allergy to potassium iodide or gadolinium
- Patients on dialysis or with eGFR less than 30 cc/min/1.73 m2 (cannot undergo gadolinium-enhanced cardiac MRI)
- Received heparin or heparin analogs within 7 days before 124I-Evuzumitide administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
A
Ahmad Masri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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