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

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called iodine-124 evuzumitide (also known as AT-01) in patients with a condition called systemic amyloidosis, specifically focusing on those with transthyretin amyloid cardiomyopathy (ATTR-CM). The main goals are to see how this medication is distributed in the body and how well it is taken up by different organs, particularly the heart. Participants will have special imaging tests, like PET/MRI or PET/CT scans, to help researchers understand the disease better. Some patients may return for follow-up scans after 6 to 12 months to see how things have changed.

To join the study, participants need to meet certain criteria. They should have systemic amyloidosis with organ involvement, be carriers of specific mutations, or have certain related conditions like multiple myeloma. Participants must be willing to consent and complete the study procedures. However, individuals with severe claustrophobia, certain allergies, or specific kidney issues may not be eligible. This study is currently recruiting participants of all genders between the ages of 65 and 87. If you or a loved one are considering participating, you can expect a thorough evaluation and the chance to contribute to important research that may improve understanding and treatment of amyloidosis.

Gender

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Eligibility 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