Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-90
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
124I-Evuzamitide
Diagnostic testAmyloid reactive protein used as imaging agent to detect systemic amyloidosis
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients with ATTR-CMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
I-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 scanSecondary outcomes
1
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 scan2
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 scan3
Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide
Time frame
During baseline scan and follow up scan4
Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake
Time frame
During baseline scan and follow up scanSponsors and contacts
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Source ClinicalTrials.gov