Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Echocardiogram marker measurements pre ABC chemo and post ABC
研究概览
简要总结
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).
详细描述
Cardiac toxicity is a significant potential complication for patients receiving anthracycline chemotherapy. Cells in the cardiovascular system have limited regenerative capability, making them susceptible to long term adverse effects from these chemotherapeutic agents. The ability to detect subclinical changes in cardiac function will allow clinicians to use proven treatments to prevent further progression in this vulnerable population. The current standard testing uses echocardiography, which is not as sensitive as cardiac MRI or serum biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that have received anthracycline based chemotherapy
- •Age: 8 years old - 25 years old
- •Subjects that do not require sedation for cardiac MRI.
- •Subjects must have completed treatment in the last 10 years
排除标准
- •Patients with significant congenital heart defects
- •Patients with renal injury or renal failure, defined as an estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area), as previously calculated)
- •Patients that require sedation for a cardiac MRI
- •Subjects that are pregnant or lactating
- •Patients with contraindications to a cardiac MRI:
- •Cardiac pacemaker or implantable defibrillator
- •Cerebral aneurysm clip
- •Neural stimulator
- •Metallic ocular foreign body
- •Any implanted device (i.e. insulin pump, drug infusion device)
- •Claustrophobia
- •Metal shrapnel or bullet
- •Investigator assessment of inability to comply with protocol
- •Unable/unwilling to lie still throughout the research procedure
- •Persons with cognitive impairment
结局指标
主要结局
Echocardiogram marker measurements pre ABC chemo and post ABC
时间窗: At the end of each cardiac MRI exam through study completion, up to 5 years
•Measure echocardiogram markers on pre anthracycline based chemotherapy (ABC) and post ABC echocardiograms, using standard echocardiogram measurements and speckle tracking.
次要结局
- Detection of cardiac toxicity on MRI and echocardiogram(At the end of each cardiac MRI exam through study completion, up to 5 years)
- Serum biomarkers correlation(At the end of the study, up to 10 years)
研究者
Niti Dham
MD
Children's National Research Institute