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

Recruiting

• Conditions: Chemotherapy Induced Cardiotoxicity
• Interventions: Other: Cardiac magnetic resonance imaging

• Registration Number: NCT03301389
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Patient with breast cancer

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Cardiac magnetic resonance imaging	-
Anthracycline-based chemotherapy (3 months)	Cardiac magnetic resonance imaging	Patients who received anthracycline-based chemotherapy 3 months ago
Other therapy group	Cardiac magnetic resonance imaging	Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy)
Pretreatment group	Cardiac magnetic resonance imaging	Patients in pretreatment state
Anthracycline-based chemotherapy (6 months)	Cardiac magnetic resonance imaging	Patients who received anthracycline-based chemotherapy 6 months ago
Anthracycline-based chemotherapy (more than 1 year ago)	Cardiac magnetic resonance imaging	Patients who received anthracycline-based chemotherapy more than 1 year ago

Primary Outcome Measures

Name	Time	Method
Decrease in LVEF (left ventricular ejection fraction)	2 years after CMR scanning	Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF \< 50%

Secondary Outcome Measures

Name	Time	Method
MACE (Major adverse cardiac events)	2 years after CMR scanning

Trial Locations

Locations (1)

Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of