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

NCT ID: NCT03301389

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Chemotherapy Induced Cardiotoxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Cardiac magnetic resonance imaging

Intervention Type OTHER

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

Cardiac magnetic resonance imaging

Intervention Type OTHER

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

Cardiac magnetic resonance imaging

Intervention Type OTHER

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

Cardiac magnetic resonance imaging

Intervention Type OTHER

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

Cardiac magnetic resonance imaging

Intervention Type OTHER

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)

Cardiac magnetic resonance imaging

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with breast cancer

Exclusion Criteria

* Contraindication of MRI
* Failure with informed consent
* Fail to scan screening protocol
Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Byoung Wook Choi, MD

Role: primary

82-2228-7400

References

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Hong YJ, Han K, Lee HJ, Hur J, Kim YJ, Kim MJ, Choi BW. Assessment of Feasibility and Interscan Variability of Short-time Cardiac MRI for Cardiotoxicity Evaluation in Breast Cancer. Radiol Cardiothorac Imaging. 2024 Feb;6(1):e220229. doi: 10.1148/ryct.220229.

Reference Type DERIVED
PMID: 38329404 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32493217 (View on PubMed)

Other Identifiers

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4-2016-0730

Identifier Type: -

Identifier Source: org_study_id

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