Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03575650
Eligibility Criteria:
Inclusion Criteria:
1. Female unilateral BC patients
2. Primary breast conserving surgery or mastectomy for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
3. Age between 40-70 years at time of chemotherapy/radiotherapy
4. WHO performance status 0-1
5. Planned radiotherapy to the breast/chest wall with or without the lymph node areas
6. Radiotherapy based on planning CT-scan, using either 3D CRT, (partial) IMRT or (partial) VMAT/RapidArc with or without deep inspiration breath-hold
7. Adjuvant systemic chemotherapy (before or after radiotherapy)
8. Written informed consent
Exclusion Criteria:
1. Male BC patients
2. M1 disease (metastatic BC)
3. Previous thoracic or mediastinal radiation
4. Neo-adjuvant chemotherapy not allowed
5. Targeted HER2 therapy not allowed
6. Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
7. Contraindications to injection of iodinated contrast such as allergy or renal failure
8. Pregnancy or lactation
9. Atrial fibrillation detected during electrocardiogram before chemotherapy/radiotherapy
10. Abnormal echocardiography before chemotherapy/radiotherapy defined as: LVEF \<50%, longitudinal strain \<-16%, longitudinal strain rate \<-1%, and/or abnormal wall motion
11. Presence of myocardial infarction detected during cMRI before chemotherapy/radiotherapy
12. cMRI or cCT results before chemotherapy/radiotherapy requiring revascularisation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03575650
Study Brief:
Protocol Section:
NCT03575650