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NCT04046315 Clinical Trial

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

Breast Cancer Clinical Trial

— EARLY-CATCH  

Official title:
Early Detection of Cardiac Damage With CMR in Women With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04046315
Other study ID # 108818
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date March 31, 2021

Study information
Verified date August 2019
Source Radboud University
Contact Yvonne Koop, MSc
Phone +31 24-3616785
Email Yvonne.Koop@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 55
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CMR
GLS measurement with CMR

Locations
Country Name City State
Netherlands Radboud University Medical Center Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline A relative reduction in Global Longitudinal Strain (GLS) assessed with CMR Baseline and 2 weeks after the last chemotherapy cycle
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