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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03301389
Enrollment
2000
Registered
2017-10-04
Start date
2016-12-01
Completion date
2025-01-31
Last updated
2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Induced Cardiotoxicity

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.

Interventions

OTHERCardiac 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
17 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patient with breast cancer

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in LVEF (left ventricular ejection fraction)1 year after CMR scanningDecrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF \< 50%

Secondary

MeasureTime frame
MACE (Major adverse cardiac events)1 year after CMR scanning

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026