Breast Cancer, Cardiotoxicity, Myocardial Damage
Conditions
Keywords
breast cancer, antracyclines, cardiotoxity, myocardial damage, MRI, T2 mapping, diastolic function, echocardiography, early detection, strain analysis
Brief summary
Anthracyclines (e.g. Doxorubicin) are an important and highly effective chemotherapeutic. They are used in various tumor entities and are established for breast cancer treatment. The most significant prognostic side effect is cardiotoxicity, which occurs in up to 50 patients. Female gender must be considered an independent risk factor for the incidence and severity of associated heart failure. The aim of this study is to demonstrate that dose-dependent anthracycline-induced cardiotoxicity has a measurable effect on T2 mapping on MRI. The second aim is to demonstrate if the combination of diastolic strain (echo and MRI) and T2 mapping can detect earlier anthracycline-induced myocardial damage than via the established method of the echocardiographic measurement of LV-EF and the conventional quantification of diastolic function.
Detailed description
In order to answer the question, patients with breast cancer, who will undergo a chemotherapeutic treatment with antracycline, will be examined before chemotherapy (including cmr and echocardiography) and after chemotherapy at different times within one year.
Interventions
DIAGNOSTIC_TESTCardiac MRI and echocardiography, laboratory parameters
Cardiac MRI including cine imaging (volumetric determination of LV-EF), late gadolinium enhancement, strain analysis, T1 mapping and T2 mapping Echocardiography including 3D-EF, diastolic function and strain analysis Determination of laboratory parameters including cardiac enzymes (Troponin T and high sensitivity Troponin T) and cardiac markers (BNP and NT-pro BNP)
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned therapy with an anthracycline and at least 1 year follow up * \>18 years of age * written informed consent
Exclusion criteria
* prior cardiovascular disease * diabetes mellitus * previous therapy with anthracyclines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50% | after 12 months | volumetric determination of LV-EF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of the left ventricular global longitudinal strain (GLS) by over 15% | after 12 months | determination of GLS via strain analysis |
Countries
Germany
Outcome results
None listed