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

NCT ID: NCT04046315

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Cardiotoxicity Breast Cancer Chemotherapy Induced Systolic Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CMR

GLS measurement with CMR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saloua El Messaoudi, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Angela Maas, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Robin Nijveldt, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

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Radboud University Medical Center

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Yvonne Koop, MSc

Role: CONTACT

+31 24-3616785

Facility Contacts

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Yvonne Koop, MSc

Role: primary

Other Identifiers

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108818

Identifier Type: -

Identifier Source: org_study_id

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