NCT05758493RecruitingPhase 2
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 25 Jan 2023
- Start date
- 10 Jan 2023
- Primary completion date
- 10 Dec 2027
- Lead sponsor
- Oregon Health and Science University
- Diseases
- Amyloidosis
- NCT number
- NCT05758493
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 10 Jan 2023 to the primary completion date, 10 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration
Other illness
- Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol
Lab values
- Has a known allergy to potassium iodide treatment or to gadolinium.
- Patients on dialysis or those with eGFR \<30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI.
Who the study is looking for
- 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.
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
Related publications
- 124Iodine Evuzamitide Positron Emission Tomography in Patients With Established or Suspected Cardiac Amyloidosis.JACC Cardiovasc Imaging · 2026 · PMID 42670739
This page is information, not medical advice. Discuss any trial with your doctor.