Implication of MEDIcal low dose RADiation exposure _ EARLY detection of cardiovascular (HEART) changes after radiotherapy for breast cancer (MEDIRAD-EARLY HEART) - MEDIRAD-EARLY HEART

niversitair Medisch Centrum Groningen0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•* Female unilateral breast cancer patients
•* Treated with primary breast conserving surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
•* Age between 40-75 years at time of start radiotherapy
•* WHO performance status 0-1
•* Planned for radiotherapy alone to the breast with or without the lymph node areas
•* Radiotherapy based on planning-CT scan using either 3D-CRT, IMRT, or VMAT/RapidArc
•* Written Informed consent

•Non inclusion criteria:
•* Male breast cancer patients
•* Neoadjuvant or adjuvant chemotherapy
•* M1 disease (metastatic breast cancer)
•* Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
•* Previous thoracic or mediastinal radiation
•* Contraindications to injection of iodinated contrast such as allergy or renal failure
•* Pregnancy or lactation;Exclusion criteria
•* Atrial fibrillation detected during electrocardiogram before radiotherapy
•* Abnormal echocardiography before radiotherapy defined as: LVEF<50%; longitudinal strain < -16%; longitudinal strain rate <-1%, and/or abnormal wall motion
•* Presence of myocardial infarction detected during MRI before radiotherapy
•* CTCA or cardiac MRI results before radiotherapy requiring revascularisation

发起方