Evaluating Iodine-124 Evuzumitide in Patients with Systemic Amyloidosis
Official title: Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Run by Oregon Health and Science University · NCT05758493 · Data updated 2026-11-12
This study is testing how a new imaging agent called iodine-124 evuzumitide works in people with systemic amyloidosis, especially those with heart issues, to see how it affects their organs and overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | January 10, 2023 |
| Main results expected | December 10, 2027 |
| Study ends | March 10, 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT05758493 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with systemic amyloidosis showing organ involvement, carriers of pathogenic transthyretin mutations, or those with related conditions like multiple myeloma.
✕Probably not a fit
Patients with severe claustrophobia, known allergies to study-related substances, or those on dialysis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study is a single center prospective evaluation of 124I-evuzumitide in patients diagnosed with systemic amyloidosis, specifically focusing on transthyretin amyloid cardiomyopathy (ATTR-CM). The research aims to identify and characterize how 124I-evuzumitide distributes and is taken up in the body, correlating this uptake with the structure and function of various organs, particularly the heart. Eligible participants will undergo imaging procedures, primarily using hybrid positron emission tomography and magnetic resonance imaging (PET/MRI), with alternatives for those unable to have MRI. Data collected will include clinical demographics, imaging results, and laboratory findings to better understand the disease's impact on patients.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of systemic amyloidosis and improve diagnostic and treatment strategies for affected patients.
How similar studies have gone: While this approach is novel in its specific application, similar imaging studies have shown promise in understanding amyloidosis and related conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Patient willing to consent for the study and undergo the study procedures. Exclusion Criteria: 1. Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol 2. Has a known allergy to potassium iodide treatment or to gadolinium. 3. Patients on dialysis or those with eGFR \<30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI. 4. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration
Where it's running
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Oregon Health & Science University
Portland, Oregon, United States Recruiting
Study contacts
- Study coordinator: Ahmad Masri, MD
- Email: masria@ohsu.edu
- Phone: 503-418-1964
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Acoramidis for ATTR-CM: Cardiac Imaging Study
This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.
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Preventing transthyretin amyloidosis in young carriers of a genetic variant
This study is testing if a medication called acoramidis can help prevent transthyretin amyloidosis in young adults who carry a specific genetic variant that puts them at risk for the disease.
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Evaluating the prevalence of transthyretin amyloidosis in heart failure patients
This study is trying to find out how common transthyretin amyloidosis is in older heart failure patients to help catch it early for better treatment.
-
Long-term safety of eplontersen in adults with transthyretin amyloidosis, including those with prior liver transplant or severe liver impairment
This study will see if eplontersen remains safe over time for adults with transthyretin amyloidosis, including people who have had a liver transplant or have severe liver problems.
-
Annular ligament biopsy during endoscopic carpal tunnel surgery to screen for transthyretin amyloidosis
This study tests whether a biopsy of the annular ligament during carpal tunnel surgery can reliably indicate transthyretin amyloidosis and match the results of the standard synovial biopsy.
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Heart-Healthy Rehab for Cardiac Amyloidosis
This study tests whether a 5-week supervised cardiac rehabilitation program can help people with cardiac amyloidosis improve exercise capacity and quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.