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临床试验/NCT02348684
NCT02348684已完成不适用

Pilot Study to Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation in Women Treated for Node Positive Breast Cancer With Three- Dimensional Conformal Radiation Therapy (3DCRT)

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Cardiac MRI Parameters

研究概览

简要总结

The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.

详细描述

Identification of "safe" dose volume constraints (DVC) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need targeted follow-up for their long term cardiac risk. Two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2. Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT) for detecting and measuring cardiac injury.

An MRI, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

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 95 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

排除标准

  • Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

结局指标

主要结局

Cardiac MRI Parameters

时间窗: day of MRI scan

Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).

次要结局

  • Correlate Cardiac MRI Parameters(the day of MRI)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Carmen Bergom

Associate Professor

Medical College of Wisconsin

研究点 (1)

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