Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping

Conditions
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Breast Cancer, Myocardial Damage, Cardiotoxicity

Intervention / Treatment
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* Diagnostic Test: Cardiac MRI and echocardiography, laboratory parameters


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Cardiac 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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50% | volumetric determination of LV-EF | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of the left ventricular global longitudinal strain (GLS) by over 15% | determination of GLS via strain analysis | after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, antracyclines, cardiotoxity, myocardial damage, MRI, T2 mapping, diastolic function, echocardiography, early detection, strain analysis