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.
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To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Timeframe: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Timeframe: Up to 60 days after administration of I-124 evuzamitide