Early Detection of Cardiac Damage With CMR in Women With Breast Cancer (EARLY-CATCH)

March 12, 2020 updated by: Radboud University Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Recruiting
        • Radboud University Medical Center
        • Contact:
          • Yvonne Koop, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population will be recruited from the general BC population receiving (neo-) adjuvant chemotherapy. Patients with a new diagnosis of malignant neoplasm of the breast, codes C50.0-C50.9, according to the World Health Organization International Classification of Diseases (WHO-ICD) will be eligible for participation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Study Chair: Saloua El Messaoudi, PhD, Radboud University Medical Center
  • Principal Investigator: Angela Maas, PhD, Radboud University Medical Center
  • Study Chair: Robin Nijveldt, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108818

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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