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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Amyloid reactive protein used as imaging agent to detect systemic amyloidosis
Oregon Health & Science University
Portland, Oregon, United States
RECRUITINGI-124 evuzamitide diagnostic accuracy
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, compared to SoC site diagnosis. We will assess: * The sensitivity of PET/MRI with 124I-evuzamitide PET/MRI for the diagnosis of cardiac amyloidosis. * The specificity of PET/MRI with 124I-evuzamitide for the diagnosis of cardiac amyloidosis.
Time frame: At baseline scan
Quantitative measures
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on quantitative scan interpretation, compared to SoC site diagnosis. We will assess the sensitivity and specificity of various quantitative measures, and evaluate inter- and intra-reader agreement.
Time frame: At baseline scan
Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake
Pearson Correlation Coefficient of stage of amyloidosis (Mayo Staging System) and SUV (124I-Evuzamitide)
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.
Incidence of related treatment-emergent (S)AEs from time of study drug administration to Day 7
Time frame: 7 days from baseline scan
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