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124 I-Evuzamitide Positron Emission Tomography/Computed Tomography for Diagnosing Cardiac Amyloidosis
Key result
124I-evuzamitide PET/CT demonstrates 94% sensitivity and high specificity for diagnosing cardiac amyloidosis.
- Sensitivity 94%
- 95% CI 85-98
- P<.001
- n=170
Why the trial?
Cardiac amyloidosis is diagnosed late, and current imaging cannot reliably detect and quantify both AL and ATTR disease. REVEAL asked whether 124I-evuzamitide PET/CT, a pan-amyloid tracer, accurately diagnoses cardiac amyloidosis.
Does 124I-evuzamitide PET/CT accurately diagnose cardiac amyloidosis in adults with suspected disease?
Population
170 adults with suspected cardiac amyloidosis analysed (195 enrolled); median age 72
Comparison
124I-evuzamitide PET/CT vs blinded standard-of-care diagnostic adjudication
Design
Prospective multicenter single-group diagnostic study (18 US centers)
Follow-up
60 days
Authors
Discussion
No takes yet. Share an insight, caveat, or question.
Where experts stand
Experts view the REVEAL trial as a landmark validation of 124I-evuzamitide PET/CT for diagnosing cardiac amyloidosis, with strong enthusiasm and no notable dissent about its potential to simplify a historically complex diagnostic workup.
The reaction to REVEAL is uniformly positive, with clinicians and investigators calling this the first rigorously conducted multicenter imaging trial in cardiac amyloidosis and describing results that could reshape diagnosis. The lead investigator highlights the potential for a single scan to confirm or exclude the disease across amyloid types and organs. The open question is whether and how quickly this tracer moves toward regulatory approval and integration into clinical practice.
Agreement
Clinicians agree that 124I-evuzamitide PET/CT has the potential to reshape cardiac amyloidosis diagnosis by offering a single noninvasive test that can confirm or exclude the disease.
2 clinicians say this directly
What they’re arguing about
supportiveneutralcautiouscritical
Counts are expert takes we classified by axis. Tap a row to see the takes behind its count.
Still unclear
Whether regulatory approval and clinical adoption will follow quickly, and how 124I-evuzamitide PET/CT will fit alongside existing diagnostic pathways including bone scintigraphy and biopsy. Its role in longitudinal tracking of cardiac amyloid burden also remains to be defined in future studies.
Key expert perspectives
A single scan can confirm or exclude cardiac amyloidosis across amyloid types and organs
Dorbala, the lead investigator, emphasizes that a negative scan excludes and a positive scan confirms cardiac amyloidosis. She highlights the tracer's ability to image multiple amyloid types and multiple organs, and its potential to differentiate amyloid subtypes alongside laboratory testing and track amyloid burden over time.
ABAhmed BennisHeart Failure / Cardiomyopathy · Centre Hospitalier Universitaire Hassan IIResults readoutAug 31
124I-evuzamitide PET provides excellent diagnostic accuracy in cardiac amyloidosis
Bennis highlights that the tracer provides excellent diagnostic accuracy in patients known or suspected to have cardiac amyloidosis.
Distilled from their postX post
KD
Konstanze Diefenbach · Head of Radiology R&D, Bayer Pharmaceuticals · Aug 30 Results readout Expresses excitement about the positive topline results and anticipation for sharing the data with the scientific community. Original post
Implication
Supports noninvasive diagnosis of cardiac amyloidosis; extends direct PET imaging beyond TTR subtypes.
Key Points
- To evaluate the sensitivity and specificity of 124I-evuzamitide PET/CT for the diagnosis of cardiac amyloidosis in patients undergoing clinical evaluation.
- Prospective, multicenter (18 US centers) single-group diagnostic trial (NCT06788535) enrolling 195 adults suspected of having cardiac amyloidosis, with 170 patients included in the final analysis.
- Participants received oral potassium iodide followed by 1 mCi intravenous 124I-evuzamitide, undergoing PET/CT imaging 3 to 5 hours post-injection.
- Three blinded imaging specialists independently assessed PET/CT tracer uptake, while three blinded amyloidosis experts adjudicated clinical diagnoses using standard-of-care diagnostic algorithms with a 60-day follow-up.
- 124I-evuzamitide PET/CT demonstrated an overall sensitivity of 94% (95% CI, 85%-98%; P < .001) and an overall specificity of 86% (95% CI, 77%-92%; P < .001).
- The imaging approach yielded a positive predictive value of 85% (95% CI, 75%-92%) and a negative predictive value of 94% (95% CI, 87%-98%).
Evidence details
What drove the result?
| Outcome | PET/CT |
|---|---|
| Sensitivity for cardiac amyloidosis | 94% (95% CI 85-98) |
| Coprimary endpoint · p<0.001 | |
| Specificity for cardiac amyloidosis | 86% (95% CI 77-92) |
| Coprimary endpoint · p<0.001 | |
| Positive / negative predictive value | 85% / 94% |
| Secondary accuracy measures · PPV 95% CI 75-92; NPV 95% CI 87-98 | |
Limitations & tradeoffs
Design limitations
Single-group design measured accuracy against blinded expert adjudication of the standard-of-care algorithm rather than histology or a comparator tracer, and safety is described only qualitatively ('acceptable safety profile') with no adverse event rates.
Statistical certainty
25 of 195 enrolled patients were not included in the analysis; reasons are not given in the record.
Representation
Patients with an established amyloidosis diagnosis were excluded, so performance applies to first-time diagnostic evaluation.
Structured PICO
Does 124I-evuzamitide PET/CT accurately diagnose cardiac amyloidosis in adults with suspected disease?
P
Population
170 adults with suspected cardiac amyloidosis, excluding those with an established diagnosis, evaluated with 124I-evuzamitide PET/CT and followed for 60 days.
I
Intervention
124I-evuzamitide PET/CT (1 mCi IV, scanned 3 to 5 hours post-injection, with oral potassium iodide 130 mg for 3 days).
C
Comparator
Standard-of-care diagnostic algorithm (adjudicated by expert clinical amyloidosis physicians blinded to PET/CT data).
O
Outcome
Sensitivity and specificity of 124I-evuzamitide for the diagnosis of cardiac amyloidosis.surrogate
Main Result
Effect estimate: Sensitivity 94% (95% CI 85-98)
p-value: p=<.001
124I-evuzamitide PET/CT is a highly sensitive (94%) and specific (86%) noninvasive imaging modality for diagnosing cardiac amyloidosis.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Dorbala et al. (2026) studied suspected cardiac amyloidosis (n=170). 124I-evuzamitide PET/CT vs. standard-of-care diagnostic algorithm was evaluated on sensitivity and specificity of 124I-evuzamitide for the diagnosis of cardiac amyloidosis (Sensitivity 94%, 95% CI 85-98, p=<.001). 124I-evuzamitide PET/CT demonstrated high diagnostic accuracy for cardiac amyloidosis, with a sensitivity of 94% (95% CI 85-98; P<.001) and specificity of 86% (95% CI 77-92; P<.001).