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

NCT04046315 | Unknown

• 1 other identifier: 108818
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Breast Cancer; Chemotherapy Induced Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

CMR DIAGNOSTIC_TEST

GLS measurement with CMR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Saloua El Messaoudi, PhD

  Radboud University Medical Center

  STUDY CHAIR

• Angela Maas, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Robin Nijveldt, PhD

  Radboud University Medical Center

  STUDY CHAIR

Central Study Contacts

Yvonne Koop, MSc

CONTACT

+31 24-3616785; Yvonne.Koop@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 6, 2019
• Study Start: March 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: March 16, 2020

Record last verified: 2019-08

Locations

NL (1)