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Clinical Trials/NCT03301389
NCT03301389
Recruiting
Not Applicable

Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)

Yonsei University1 site in 1 country2,000 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chemotherapy Induced Cardiotoxicity
Sponsor
Yonsei University
Enrollment
2000
Locations
1
Primary Endpoint
Decrease in LVEF (left ventricular ejection fraction)
Status
Recruiting
Last Updated
7 years ago

Overview

Brief Summary

Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. The clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship.

Left ventricular (LV) functional assessment is the standard of reference to diagnose chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-, radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This study aimed to achieve early detection of chemotherapy- or radiation therapy-induced cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients treated for breast cancer.

Detailed Description

Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of cardiotoxicity will be conducted in patients with breast cancer who have received or are planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping and cine imaging of the LV myocardium.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
January 2025
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient with breast cancer

Exclusion Criteria

  • Contraindication of MRI
  • Failure with informed consent
  • Fail to scan screening protocol

Outcomes

Primary Outcomes

Decrease in LVEF (left ventricular ejection fraction)

Time Frame: 2 years after CMR scanning

Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF \< 50%

Secondary Outcomes

  • MACE (Major adverse cardiac events)(2 years after CMR scanning)

Study Sites (1)

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