Overview

Evuzamitide as SPECT/CT Imaging Agent for Diagnosis of Transthyretin Amyloidosis

Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
This is a single center, prospective cohort study that is evaluating the ability of 124I-evuzamitide PET scanning to: (1) identify extra-cardiac amyloid deposits in patients with ATTRwt-CA and the Val122Ile variant; (2) to detect cardiac TTR amyloidosis in subjects with heart failure, increased wall thickness but only grade 1 Tc99PYP scans who are not currently diagnosed with ATTR-CA; and (3) to detect cardiac ATTR in allele carriers of TTR variants (Phe64Leu, late onset Val30Met) that are associated with cardiac amyloidosis but have PYP scans not diagnostic of ATTR-CM. If 124I-evuzamitide PET scanning is shown to be valuable in any of these three cohorts, it would address critical unmet needs regarding the diagnosis and extent of disease in ATTR-CM. Consented eligible patients will undergo a single 124I-evuzamitide PET scan. Clinically available demographic, clinical and phenotypic data that is collected as part of routine clinical care will be used to characterize the type, severity, and stage of ATTR-CM.
Phase:
Phase 2
Details
Lead Sponsor:
Columbia University
Collaborator:
Attralus, Inc.