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

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.

Timeline

Start

2025-01-14

Primary completion

2026-04-08

Completion

2026-04-09

Publications

• Background Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.
• Background Clerc OF, Cuddy SAM, Robertson M, Vijayakumar S, Neri JC, Chemburkar V, Kijewski MF, Di Carli MF, Bianchi G, Falk RH, Dorbala S. Cardiac Amyloid Quantification Using 124I-Evuzamitide (124I-P5+14) Versus 18F-Florbetapir: A Pilot PET/CT Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1419-1432. doi: 10.1016/j.jcmg.2023.07.007. Epub 2023 Sep 6.

Drugs

Indications