early heartdamage Subclinical cardiovascular changes
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are defined as a mean decrease in Global Longitudinal Strain or Global Longitudinal Strain Rate, determined by cardiac ECHO-ST, of at least 2.5% between baseline and 24 months after RT (Erven et al, Int J Radiation Oncol Biol Phys, 2012; Lo et al, In J Radiation Oncol Biol Phys, 2015). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are other imaging and circulating biomarkers, defined as: * Secondary echocardiographic measurements are: o Left ventricular ejection fraction using Simpson*s biplane method o Left ventricular end-diastolic volume using Simpson*s biplane method o Left ventricular end-systolic volume using Simpson*s biplane method o Left-ventricular end-diastolic diameter using M-mode o Left ventricular mass measured according ASE/EAE guidelines o Global and segmental radial strain rate o E/A wave ratio o E/Ea wave ratio (lateral annulus) o TAPSE (triscuspid annular plane systolic excursion) o Tricuspid annular S wave o Pulmonary artery systolic pressure (based on the peak tricuspid regurgitation velocity estimate and by assuming a right atrial pressure of 5 mmHg) o Left ventricular outflow tract diameter o Left ventricular outflow tract velocity time integral o Heart rate o Cardiac output measured by multiplying heart rate by stroke volume * CT: to measure anatomical changes in coronary arteries assessed by cardiac CT occurring 24 months after RT compared with baseline before RT start. o Individual description of stenosis or plaques of the 15 segments of the coronary arteries; left main coronary artery (LM); left anterior descending artery (LAD), left circumflex artery (LX) and right coronary artery (RCA) and evaluation of change in CAC score. o The progression atherosclerosis will be defined as an increase of the number of coronary segments containing any plaque and as an increase of the calcium score, of at least 15% between baseline and 24 months after RT. * MRI: to evaluate myocardial tissue abnormalities assessed by cardiac MRI occurring 6 to 24 months after RT compared with baseline before RT start. o Cardiac MRI-parameters include: morphology, function, tissue characterization by delayed enhancement and pre-/post-contrast T1 mapping (at 15 minutes). o The corresponding main MRI-endpoint is defined by an increase of the native | — |
Countries
Netherlands
Outcome results
None listed