New PET/CT Scan Imaging Agent May Help Diagnose Suspected Cardiac Amyloidosis

Sharmila Dorbala, MD, MPH

Cardiac amyloidosis is a serious condition caused by amyloid building up in the heart, leading to heart dysfunction and failure. But diagnosis remains challenging and no single test can definitively rule out or confirm the condition.

A team of researchers led by Sharmila Dorbala, MD, MPH, of the Mass General Brigham Heart and Vascular Institute(opens in new tab), set out to evaluate how a new PET/CT imaging agent called ¹²⁴I-evuzamitide can help to diagnose cardiac amyloidosis. The imaging agent is designed to bind directly to amyloid deposits of all subtypes.

The team conducted a phase 3 prospective study called REVEAL, funded by Bayer, at 18 U.S. centers that enrolled approximately 200 adults being evaluated for suspected cardiac amyloidosis.

The new test,¹²⁴I-evuzamitide PET/CT, showed 94% sensitivity and 86% specificity for diagnosing cardiac amyloidosis. The test also had a 94% negative predictive value, meaning a negative scan strongly suggested the disease wasn’t present.

The REVEAL study was the first report of a rigorously conducted clinical trial of an imaging agent for diagnosing cardiac amyloidosis.

In this study, the authors conclude that ¹²⁴I-evuzamitide could be a useful diagnostic for helping to evaluate patients with suspected cardiac amyloidosis, with the potential to simplify the diagnostic process for patients and clinicians, enable earlier detection and treatment, and more accurately assess disease severity.

Published in JAMA on August 30, 2026 | Read the paper: “124I-Evuzamitide Positron Emission Tomography/Computed Tomography for Diagnosing Cardiac Amyloidosis(opens in new tab)”

Summary reviewed by: Sharmila Dorbala, MD, MPH, lead/senior author