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

Completed

Conditions: early heartdamage
Subclinical cardiovascular changes
10082206

Registration Number: NL-OMON44264

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

* 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

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are defined as a mean decrease in Global Longitudinal<br /><br>Strain or Global Longitudinal Strain Rate, determined by cardiac ECHO-ST, of at<br /><br>least 2.5% between baseline and 24 months after RT (Erven et al, Int J<br /><br>Radiation Oncol Biol Phys, 2012; Lo et al, In J Radiation Oncol Biol Phys,<br /><br>2015).</p><br>

Secondary Outcome Measures