Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 124I-Evuzamitide.
- Who it may be relevant to
- Registry conditions: Amyloidosis, Transthyretin Amyloidosis. Basic parameters: 40 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 124I-Evuzamitide
Amyloid reactive protein used as imaging agent to detect systemic amyloidosis
Primary outcome measures
- I-124 evuzamitide diagnostic accuracy [Time frame: At baseline scan]
Secondary outcome measures (7)
- Quantitative measures [Time frame: At baseline scan]
- Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake [Time frame: At baseline scan]
- Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide [Time frame: During baseline scan and follow up scan]
- Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake [Time frame: During baseline scan and follow up scan]
- Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake [Time frame: During baseline scan and follow up scan]
- Proportion of patients with ATTR-CM and MGUS or smoldering myeloma who are correctly classified as ATTR-CM based on 124I-Evuzamitide distribution and uptake [Time frame: During baseline scan]
- To evaluate the safety of a single intravenous administration of I-124 evuzamitide. [Time frame: 7 days from baseline scan]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol
- 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.
- Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Publications
- Wall JS, Martin EB, Endsley A, Stuckey AC, Williams AD, Powell D, Whittle B, Hall S, Lambeth TR, Julian RR, Stabin M, Lands RH, Kennel SJ. First in Human Evaluation and Dosimetry Calculations for Peptide 124I-p5+14-a Novel Radiotracer for the Detection of Systemic Amyloidosis Using PET/CT Imaging. Mol Imaging Biol. 2022 Jun;24(3):479-488. doi: 10.1007/s11307-021-01681-2. Epub 2021 Nov 16. PMID 34786667
Identifiers
NCT: NCT05758493 · 24299