Evaluating Iodine-124 Evuzumitide in Patients with Systemic Amyloidosis
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
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 |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05758493 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe claustrophobia, known allergies to study-related substances, or those on dialysis may not benefit from this study.
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 performed: While this approach is novel in its specific application, similar imaging studies have shown promise in understanding amyloidosis and related conditions.
Eligibility criteria
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 this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Ahmad Masri, MD
- Email: masria@ohsu.edu
- Phone: 503-418-1964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.