Early detection of imaging-derived subclinical cardiac injuries after radiotherapy and chemotherapy for breast cancer

Recruiting

• Conditions: early heart damage; Early subclinical cardiac injuries; 10082206

• Registration Number: NL-OMON48680
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 198

Inclusion Criteria

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
areas
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

Exclusion Criteria

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
failure
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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There are 3 primary endpoints, 2 for functional ESCIs and 1 for morphological<br /><br>ESCIs:<br /><br>• The change in left ventricle systolic (dys)function is determined by cECHO<br /><br>using left ventricle global longitudinal strain (LV-GLS) at 6 and 24 months<br /><br>after radiotherapy with reference to baseline.<br /><br>• The change in LV diastolic function (LV-DF) is determined by cECHO, defined<br /><br>as a decrease of the average of e* septal and e* lateral together at 6 and 24<br /><br>months after completion of radiotherapy with reference to baseline.<br /><br>• The increase of diffuse myocardial fibrosis determined by cMRI morphology,<br /><br>using LV T1 mapping, defined by an increase of the native mean LV myocardial T1<br /><br>mapping value of the entire population at 6 and 24 after completion of<br /><br>radiotherapy.</p><br>