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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 REVEAL as a landmark diagnostic study, with the trial's lead investigator and commentators describing 124I-evuzamitide PET/CT as a potential single-test solution for diagnosing cardiac amyloidosis.
The reaction to REVEAL is enthusiastically positive, with no dissenting voices among the clinicians who commented. Experts highlight the possibility that one noninvasive scan could both confirm and exclude cardiac amyloidosis across amyloid subtypes, potentially simplifying a diagnostic pathway that currently requires multiple steps. The open question is whether regulatory approval and guideline integration will follow, and how this tracer will fit alongside existing imaging and laboratory workflows.
Agreement
Commentators agree that 124I-evuzamitide PET/CT offers excellent diagnostic accuracy and could serve as a single upstream test to confirm or exclude cardiac amyloidosis.
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 agencies will approve 124I-evuzamitide on the basis of these diagnostic accuracy data, and how guidelines will position this PET tracer relative to existing bone-scintigraphy and biopsy-based pathways. Experts also flag the tracer's potential to track amyloid burden over time and image multiple organs, but real-world validation of those uses remains ahead.
Key expert perspectives
A single scan can confirm or exclude cardiac amyloidosis across amyloid types and organs
Dorbala, the trial's principal investigator, emphasizes that a negative 124I-evuzamitide PET/CT scan excludes cardiac amyloidosis and a positive scan confirms it. She notes the tracer can image multiple amyloid types and multiple organs, and when paired with appropriate laboratory testing can differentiate amyloid subtypes and track cardiac amyloid burden over time.
Ahmed BennisHeart Failure / Cardiomyopathy · Centre Hospitalier Universitaire Hassan IIResults readoutAug 31124I-evuzamitide PET provides excellent diagnostic accuracy in cardiac amyloidosis
Bennis highlights the trial's finding that 124I-evuzamitide PET delivers excellent diagnostic accuracy in patients known or suspected to have cardiac amyloidosis.
Distilled from their postX post
AM
Ahmad Masri · Aug 30 Live reporting Called REVEAL the first rigorously conducted multicenter trial of an imaging agent in cardiac amyloidosis, praising the results as amazing. X 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).