JACC. Cardiovascular imaging · 2026
124Iodine Evuzamitide Positron Emission Tomography in Patients With Established or Suspected Cardiac Amyloidosis.
СтатьяНазвание и аннотация: Перевод в очереди
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Masri Ahmad, Jahan Israt, Gillan Derrick, Alqabani Mohammad, Suits Austen, Davis Bryton, Mejia Angelica T, Raposo Helena, Ferencik Maros, Medvedova Eva, Mallak Nadine
Аннотация
BACKGROUND: 124I-evuzamitide is a pan-amyloid positron emission tomography (PET) radiotracer.
OBJECTIVES: The aim of this open-label study was to assess the performance and safety of 124I-evuzamitide PET/magnetic resonance imaging (MRI) in patients with known or suspected cardiac amyloidosis (CA).
METHODS: Consecutive patients with suspected or known CA were invited to participate in the trial and underwent imaging with 124I-evuzamitide (mean administered activity 1.05 ± 0.02 mCi), using PET/MRI preferentially and PET/computed tomography as an alternative. A positive scan was defined visually as tracer uptake in the left ventricular myocardium greater than blood pool activity by 3 expert readers. Equivocal scans were prespecified to be classified as negative (except for inter-reader agreement).
RESULTS: A total of 126 patients (mean age: 71.6 ± 10.6 years, 76.2% men) underwent 124I-evuzamitide PET/MRI (n = 123) or PET/CT (n = 3), of whom 87 (69%) received diagnoses of CA. All patients with CA had visually positive scans, and all patients without CA had visually negative scans by all 3 readers (100% sensitivity and specificity). There was disagreement on 5 patients, who were graded as having equivocal or negative scans (Fleiss's kappa = 0.94; none received a diagnosis of CA). Quantitatively, mean left ventricular/blood pool standardized uptake value ratio was 1.89 ± 0.29 and 0.91 ± 0.15 in patients with and without CA, respectively (P < 0.001). 124I-evuzamitide was well tolerated, without significant tracer-related adverse events.
CONCLUSIONS: 124I-evuzamitide PET provides excellent diagnostic accuracy in patients known or suspected to have CA and might provide a single upstream assessment for the presence or absence of CA. (Characterizing Iodine-124 Evuzumitide [AT-01] in Systemic Amyloidosis; NCT05758493).
OBJECTIVES: The aim of this open-label study was to assess the performance and safety of 124I-evuzamitide PET/magnetic resonance imaging (MRI) in patients with known or suspected cardiac amyloidosis (CA).
METHODS: Consecutive patients with suspected or known CA were invited to participate in the trial and underwent imaging with 124I-evuzamitide (mean administered activity 1.05 ± 0.02 mCi), using PET/MRI preferentially and PET/computed tomography as an alternative. A positive scan was defined visually as tracer uptake in the left ventricular myocardium greater than blood pool activity by 3 expert readers. Equivocal scans were prespecified to be classified as negative (except for inter-reader agreement).
RESULTS: A total of 126 patients (mean age: 71.6 ± 10.6 years, 76.2% men) underwent 124I-evuzamitide PET/MRI (n = 123) or PET/CT (n = 3), of whom 87 (69%) received diagnoses of CA. All patients with CA had visually positive scans, and all patients without CA had visually negative scans by all 3 readers (100% sensitivity and specificity). There was disagreement on 5 patients, who were graded as having equivocal or negative scans (Fleiss's kappa = 0.94; none received a diagnosis of CA). Quantitatively, mean left ventricular/blood pool standardized uptake value ratio was 1.89 ± 0.29 and 0.91 ± 0.15 in patients with and without CA, respectively (P < 0.001). 124I-evuzamitide was well tolerated, without significant tracer-related adverse events.
CONCLUSIONS: 124I-evuzamitide PET provides excellent diagnostic accuracy in patients known or suspected to have CA and might provide a single upstream assessment for the presence or absence of CA. (Characterizing Iodine-124 Evuzumitide [AT-01] in Systemic Amyloidosis; NCT05758493).