Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, Tennessee, USA.
Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, Tennessee, USA.
JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.
The noninvasive detection of cardiac amyloid, as well as deposits in other vital organs, is critical for early diagnosis and quantitative disease monitoring. Positron emission tomography is an intrinsically quantitative imaging modality suitable for high-resolution amyloid detection.
This study sought to evaluate the safety and efficacy of a novel amyloid-reactive peptide, designated p5+14, labeled with iodine-124 (I), in patients with diverse types of systemic amyloidosis.
In a single-site, open label phase 1/2 study (NCT03678259), the safety, biodistribution, and sensitivity of a single intravenous infusion of I-evuzamitide was assessed in patients with systemic amyloidosis (n = 50), asymptomatic transthyretin sequence variant carriers (n = 2), and healthy volunteers (n = 5). Subjects were administered 1.4 ± 0.2 mg of I-evuzamitide (71.5 ± 12.4 MBq) and positron emission tomography/x-ray computed tomography images acquired at 5.2 hours (Q25-Q75: 4.9-5.4 hours) postinfusion. Images were assessed visually and semi-quantitatively for positive uptake of radiotracer in the heart and other major organs.
Uptake of I-evuzamitide in the heart and other abdominothoracic organs was consistent with the patient's clinical presentation and the type of amyloidosis. The patient- and cardiac-associated sensitivity for imaging and clinical observations was 93.6% (95% CI: 82.8%-97.8%) and 96.2% (95% CI: 81.8%-99.8%), respectively. Semi-quantitative uptake of the radiotracer correlated significantly with serum N-terminal pro-B-type natriuretic peptide measurements in patients with light chain-associated amyloidosis. Cardiac uptake was not observed in any healthy volunteers. The agent was well tolerated, with 1 drug-related adverse event and no deaths.
I-evuzamitide is an amyloid-binding radiotracer capable of detecting cardiac amyloid in patients with high sensitivity.
心脏淀粉样变以及其他重要器官中淀粉样物质的非侵入性检测，对于早期诊断和定量疾病监测至关重要。正电子发射断层扫描（PET）是一种适用于高分辨率淀粉样检测的固有定量成像方式。
本研究旨在评估新型淀粉样反应肽（p5+14）碘-124（I）标记物在不同类型系统性淀粉样变性患者中的安全性和疗效。
在一项单中心、开放标签的 1/2 期研究（NCT03678259）中，评估了 50 例系统性淀粉样变性患者、2 例无症状转甲状腺素序列变异携带者和 5 例健康志愿者单次静脉输注 I-埃武单抗的安全性、生物分布和敏感性。受试者接受 1.4±0.2mg I-埃武单抗（71.5±12.4MBq），于给药后 5.2 小时（Q25-Q75：4.9-5.4 小时）行正电子发射断层扫描/计算机断层扫描（PET/CT）。通过视觉和半定量评估心脏和其他主要器官中放射性示踪剂的摄取情况。
I-埃武单抗在心和其他腹部-胸部器官中的摄取与患者的临床表现和淀粉样变性类型一致。影像学和临床观察的患者和心脏相关敏感性分别为 93.6%（95%CI：82.8%-97.8%）和 96.2%（95%CI：81.8%-99.8%）。在轻链相关性淀粉样变性患者中，放射性示踪剂的半定量摄取与血清 N 端脑钠肽前体水平显著相关。在任何健康志愿者中均未观察到心脏摄取。该药物耐受性良好，仅有 1 例与药物相关的不良事件，无死亡病例。
I-埃武单抗是一种可结合淀粉样物质的放射性示踪剂，能够以高灵敏度检测出心脏淀粉样变。
