The purpose of this multicenter, open-label, single-arm, single-dose study is to assess the sensitivity and specificity of I-124 evuzamitide for the diagnosis of cardiac amyloidosis compared to current clinical standards for diagnosis of cardiac amyloidosis. Participants will receive a positron emission tomography computed tomography (PET/CT) scan 4 hours (± 60 minutes) after administration of I-124 evuzamitide. The primary study hypotheses are that the sensitivity and specificity of I-124 evuzamitide PET/CT imaging of cardiac amyloidosis will be greater than 65% and 55%, respectively, in participants with suspected cardiac amyloidosis.
This multicenter, open-label, single-arm, single-dose study will assess the sensitivity and specificity of I-124 evuzamitide for the diagnosis of cardiac amyloidosis compared to current clinical standards for diagnosis of cardiac amyloidosis. The study consists of (i) up to a 45-day screening period, (ii) a treatment emergent period that consists of a 1-day treatment visit and safety follow-up procedures through Day 30 ± 5 days, and (iii) a Standard of Truth (SoT) Diagnostic Evaluation Period that extends from the screening period (Day -45) until either the last cardiac amyloidosis diagnostic test is completed or through Day 60, whichever is earlier. Thus, the total participant duration is up to approximately 3.5 months. The study will enroll approximately 200 participants with suspected cardiac amyloidosis at approximately 20 United States clinical sites. I-124 evuzamitide is the only study intervention; neither reference therapy nor placebo will be administered. Potassium iodide (KI) will be given orally for 3 days beginning \>30 minutes prior to intravenous administration of study intervention. PET/CT scans will be obtained approximately 4 hours after administration of study intervention. Sensitivity and specificity of I-124 evuzamitide will be determined using the classification of participants based on visual evaluation of the PET/CT images and cardiac amyloid disease status based on the clinical truth standard. An independent Clinical Adjudication Committee with expertise in cardiology, amyloidosis, and/or cardiac imaging will review the information obtained during the diagnostic evaluation (e.g., clinical history and laboratories, EMB, extracardiac biopsy, ECHOs, CMR, and bone-avid tracer cardiac SPECT) to determine if the data support a diagnosis of cardiac amyloidosis. The clinical truth standard will be based on all available information provided to the Clinical Adjudication Committee by the diagnostic evaluation. Three independent readers who are blinded to all clinical data will review deidentified PET/CT images for the presence/absence of cardiac uptake of I-124 evuzamitide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
204
A single dose of 1 mCi (± 10%) I-124 evuzamitide administered intravenously.
Mayo Clinic
Scottsdale, Arizona, United States
City of Hope - Duarte
Duarte, California, United States
University of California
San Francisco, California, United States
Yale Cardiovascular Medicine
New Haven, Connecticut, United States
Cleveland Clinic
Weston, Florida, United States
Northwestern University
Chicago, Illinois, United States
Cook County Health
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Lukes (CVIT) Saint Luke's Health System
Kansas City, Missouri, United States
...and 10 more locations
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Assessment of the sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Assessment of specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac ATTR amyloidosis
The sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac ATTR amyloidosis based on visual scan interpretation.
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac ATTR amyloidosis
The specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac ATTR amyloidosis based on visual scan interpretation
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac AL amyloidosis
The sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac AL amyloidosis based on visual scan interpretation
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac AL amyloidosis
The specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac AL amyloidosis based on visual scan interpretation
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the safety (treatment-emergent adverse events [AEs]) of a single intravenous administration of I-124 evuzamitide
Incidence of treatment-emergent AEs from Day 1 to Day 30
Time frame: Up to 30 days after administration of I-124 evuzamitide
To evaluate the safety (clinical laboratory values) of a single intravenous administration of I-124 evuzamitide
Change from Baseline in clinical laboratory values: Hematology, Serum Chemistry, Biomarker Assays, Pregnancy Testing
Time frame: Up to 30 days after administration of I-124 evuzamitide
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