Early Detection of Cardiac Damage With CMR in Women With Breast Cancer

• Conditions: Cardiotoxicity; Chemotherapy Induced Systolic Dysfunction; Breast Cancer

• Registration Number: NCT04046315
• Lead Sponsor: Radboud University Medical Center

Brief Summary

With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Study Start: 2020-03-01
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• Female
• Age ≥ 18 years
• A diagnosis of primary breast cancer
• Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
• Cardiotoxicity risk score of intermediate, high or very high risk

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Exclusion Criteria

• Previous radiotherapy or systemic cancer treatment
• Cancer metastasis
• Life expectancy of less than 6 months
• History of myocardial infarction or heart failure
• Known contra-indications for CMR
• Refusal or inability to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline	Baseline and 2 weeks after the last chemotherapy cycle	A relative reduction in Global Longitudinal Strain (GLS) assessed with CMR

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands