Investigational PET Radiotracer Meets Primary Endpoints for Diagnosing Cardiac Amyloidosis

The Phase III REVEAL study met its primary endpoints demonstrating sensitivity and specificity of the PET/CT investigational radiotracer I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, according to a press release disseminated last week by Bayer.

I-124 evuzamitide PET/CT scan
(Source: press release)

The company said the complete results will be presented at an upcoming scientific conference and that it has “plans to discuss the data and submission for regulatory approval with the FDA and other health authorities.”

The role of PET in cardiac amyloidosis, including the potential role of I-124 evuzamitide, will be among topics discussed in the ICNC2026 session Imaging Cardiac Amyloidosis: State of the Art. The session will be co-chaired by ASNC Past President Sharmila Dorbala, MD, MPH, MASNC, who is also principal investigator of the REVEAL trial. For background on I-124 evuzamitide and other pan-amyloid radiotracers, check out this ASNC interview with Jonathan S. Wall, PhD, head of the team who invented the peptides on which the radiotracer was built.