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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Induced Cardiotoxicity
• Intervention / Treatment: Other: Cardiac magnetic resonance imaging

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
    • Contact: Byoung Wook Choi, MD; Phone Number: 82-2228-7400; Email: bchoi@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The breast cancer patient with pretreatment state The breast cancer patients with the prior chemotherapy, or radiation therapy The breast cancer patients receiving prior chemotherapy, or radiation therapy The breast cancer patients with other treatments

Description

Inclusion Criteria:

• Patient with breast cancer

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Other: Cardiac magnetic resonance imaging; The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
Pretreatment group; Patients in pretreatment state	Other: Cardiac magnetic resonance imaging; The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
Anthracycline-based chemotherapy (3 months); Patients who received anthracycline-based chemotherapy 3 months ago	Other: Cardiac magnetic resonance imaging; The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
Anthracycline-based chemotherapy (6 months); Patients who received anthracycline-based chemotherapy 6 months ago	Other: Cardiac magnetic resonance imaging; The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
Anthracycline-based chemotherapy (more than 1 year ago); Patients who received anthracycline-based chemotherapy more than 1 year ago	Other: Cardiac magnetic resonance imaging; The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
Other therapy group; Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy)	Other: Cardiac magnetic resonance imaging; The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in LVEF (left ventricular ejection fraction)	Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%	1 year after CMR scanning
Decrease in LVEF (left ventricular ejection fraction)	Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF < 50%	2 years after CMR scanning

Secondary Outcome Measures

Outcome Measure	Time Frame
MACE (Major adverse cardiac events)	1 year after CMR scanning
MACE (Major adverse cardiac events)	2 years after CMR scanning

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Hong YJ, Kim GM, Han K, Kim PK, Lee SA, An E, Lee JY, Lee HJ, Hur J, Kim YJ, Kim MJ, Choi BW. Cardiotoxicity evaluation using magnetic resonance imaging in breast Cancer patients (CareBest): study protocol for a prospective trial. BMC Cardiovasc Disord. 2020 Jun 3;20(1):264. doi: 10.1186/s12872-020-01497-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (ACTUAL): October 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 4-2016-0730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No