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REVEAL - Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

NCT06788535 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Amyloidosis

Interventions

DRUG

I-124 evuzamitide

A single dose of 1 mCi (± 10%) I-124 evuzamitide administered intravenously.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Sharmila Dorbala

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-14
Primary Completion
2026-04-08
Completion
2026-04-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788535 on ClinicalTrials.gov