Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Accuracy of MyoStrain to Detect Cardiotoxicity
研究概览
简要总结
The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and Lymphomas).
详细描述
The study is a prospective, observational, single center, observational clinical study that will enroll up to 50 patients undergoing chemotherapy and/or targeted therapy with or without concomitant radiotherapy for the treatment of breast cancer or lymphoma. Enrolled subjects will be evaluated with the MyoStrain SENC CMR Imaging System that measures myocardial strain during standard Cardiac Magnetic Resonance imaging at baseline through 6 month follow-up.
The MyoStrain SENC CMR Imaging System has been approved with an EC Certificate according to Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 (CE 657862) in respect of: Design, development and manufacture of software for the quantification of cardiac MRI images. MyoStrain measures the contraction of heart muscle in one heartbeat per image plane. With 6 image planes (3 short axis & 3 long axis), a complete measure of the health of the myocardium, both regionally and globally, can be obtained within a minute without requiring contrast injection or a breath-hold.
Heart health will be monitored throughout cancer therapy to quantify the toxic effects of chemotherapy with or without a reduction in traditional measures such as ejection fraction, and the ability to reverse observed cardiotoxicity with standard heart failure therapy.
The goal of the study is to determine the ability to detect subclinical cardiotoxicity before extensive damage causes the reduction in traditional measures, which are currently used to categorize heart failure and serve as the basis of treatment guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing Chemotherapy for Cancer Treatment
- •Provided Written Informed Consent
排除标准
- •Contraindication to Magnetic Resonance Imaging
- •Pregnancy
结局指标
主要结局
Accuracy of MyoStrain to Detect Cardiotoxicity
时间窗: 6 months
Sensitivity of MyoStrain CMR Software to quantify myocardial dysfunction before changes in traditional measures including ejection fraction as ascertained by Biomarkers including BNP, Troponin, and SF-36 Quality of Life. Sensitivity will be calculated by looking at paired t-test evaluations comparing follow-up time points to baseline as to whether changes associated with administration of chemotherapy agents and/or heart failure therapy are detected.
次要结局
- Cardiotoxicity Incidence of Chemotherapy Drugs(6 months)
- Cardiotoxicity Risk Stratification(6 months)
- Efficacy of Heart Failure Therapy to Treat Cardiotoxicity(6 months)