Molecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of advanced imaging variables in response assessment.
研究概览
简要总结
This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age more than 18;
- •histological diagnosis of AL amyloidosis;
- •measurable cardiac involvement as per current response criteria (i.e. NT-proBNP >650 ng/L);
- •measurable hematologic disease (dFLC >20 mg/L);
- •adequate renal function (eGFR >30 mL/min) in order to be safely administered gadolinium;
- •absence of atrial fibrillation with uncontrolled heart rate;
- •absence of implantable cardiac devices;
- •absence of pulmonary amyloidosis histologically documented;
- •plan to start anti-plasma cell chemotherapy;
- •plan to assess response at the Pavia center after 6 months;
- •have given written informed consent to participate.
排除标准
- •non-AL amyloidosis;
- •NYHA class IV;
- •PS-ECOG >3;
- •severe allergy to paramagnetic tracer;
- •severe claustrophobia;
- •pregnant or nursing women;
研究组 & 干预措施
18F-florbetaben PET-CT scans
干预措施: [18F]Florbetaben (Drug)
结局指标
主要结局
Evaluation of advanced imaging variables in response assessment.
时间窗: 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone
The same variables considered at baseline will be measured 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone. Changes in these variables compared to baseline will be considered.
Evaluation of the prognostic relevance of advanced imaging variables.
时间窗: 12 months after diagnosis
\- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
次要结局
未报告次要终点
研究者
Giovanni Palladini
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia