Clinical trial NCT03301389: Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)
Official title: Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy Induced Cardiotoxicity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* Patient with breast cancer

Exclusion Criteria:

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

Primary outcomes:
measure: Decrease in LVEF (left ventricular ejection fraction)
timeFrame: 1 year after CMR scanning
measure: Decrease in LVEF (left ventricular ejection fraction)
timeFrame: 2 years after CMR scanning
Secondary outcomes:
measure: MACE (Major adverse cardiac events)
timeFrame: 1 year after CMR scanning
measure: MACE (Major adverse cardiac events)
timeFrame: 2 years after CMR scanning
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: 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.