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

Chemotherapy Induced Cardiotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301389
• Other study ID #: 4-2016-0730
• Status: Recruiting
• Start date: December 1, 2016
• Est. completion date: January 2025

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient with breast cancer

Exclusion Criteria:

• Contraindication of MRI

• Failure with informed consent

• Fail to scan screening protocol

Related Conditions & MeSH terms

• Cardiotoxicity
• Chemotherapy Induced Cardiotoxicity

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	MACE (Major adverse cardiac events)		1 year after CMR scanning
Secondary	MACE (Major adverse cardiac events)		2 years after CMR scanning