Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution
研究概览
简要总结
This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 4) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET/MRI). In a subgroup of patients who are unable to undergo PET/MR, computed tomography will be used instead of MRI (i.e. PET/CT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance
- •Patient willing to consent for the study and undergo the study procedures.
排除标准
- •Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol
- •Has a known allergy to potassium iodide treatment or to gadolinium.
- •Patients on dialysis or those with eGFR <30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI.
- •Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration
研究组 & 干预措施
Patients with ATTR-CM
Patients with ATTR-CM will undergo hybrid 124I-Evuzamitide PET/MRI imaging (or PET/CT) at baseline and in a subgroup, repeat imaging will be performed at an interval of 6-12 months.
干预措施: 124I-Evuzamitide (Diagnostic Test)
结局指标
主要结局
Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution
时间窗: At baseline scan
Pearson Correlation Coefficient of ECV (%) and SUV (124I-Evuzamitide) globally and at a per segment basis
I-124 evuzamitide diagnostic accuracy
时间窗: At baseline scan
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, compared to SoC site diagnosis. We will assess: * The sensitivity of PET/MRI with 124I-evuzamitide PET/MRI for the diagnosis of cardiac amyloidosis. * The specificity of PET/MRI with 124I-evuzamitide for the diagnosis of cardiac amyloidosis.
次要结局
- Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake(During baseline scan and follow up scan)
- Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake(During baseline scan and follow up scan)
- Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake(At baseline scan)
- Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide(During baseline scan and follow up scan)
- Proportion of patients with ATTR-CM and MGUS or smoldering myeloma who are correctly classified as ATTR-CM based on 124I-Evuzamitide distribution and uptake(During baseline scan)
- Quantitative measures(At baseline scan)
- To evaluate the safety of a single intravenous administration of I-124 evuzamitide.(7 days from baseline scan)
研究者
Ahmad Masri
Associate Professor
Oregon Health and Science University