NL-OMON48680招募中不适用
Early detection of imaging-derived subclinical cardiac injuries after radiotherapy and chemotherapy for breast cancer - EMIRA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Female unilateral BC patients
- •Primary breast conserving surgery or mastectomy for stage I-III invasive
- •adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
- •Age >=18 years at time of adjuvant radiotherapy/(neo)adjuvant chemotherapy
- •WHO performance status 0-1
- •Planned radiotherapy to the breast/chest wall with or without the lymph node
- •Photon radiotherapy based on planning CT-scan, using either 3D CRT, (partial)
- •IMRT, or (partial) VMAT/RapidArc with or without deep inspiration breath-hold,
- •or proton therapy in free breathing (1 of more beams technique)
- •(Neo)Adjuvant chemotherapy (before or after radiotherapy)
- •Written informed consent
排除标准
- •Male breast cancer patients
- •M1 disease (metastatic Breast cancer)
- •Previous thoracic of mediastinal radiation
- •Targeted HER2 therapy not allowed
- •Medical history of coronary artery disease and/or myocardial infarction and/or
- •atrial fibrillation
- •Contraindications to injection of iodinated contrast such as allergy or renal
- •Pregnancy or lactation
- •Atrial fibrillation detected during electrocardiogram before radiotherapy
- •Abnormal echocardiography before radiotherapy defined as: LVEF <50%, and/or
- •abnormal wall motion
- •Presence of myocardial infarction detected during cMRI before radiotherapy
- •cMRI or cCT results before radiotherapy requiring revascularisation
研究者
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