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

NCT03301389 | Unknown

• 1 other identifier: 4-2016-0730
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Induced Cardiotoxicity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• MACE (Major adverse cardiac events)

  1 year after CMR scanning

• MACE (Major adverse cardiac events)

  2 years after CMR scanning

Study Arms (6)

Control group

Other: Cardiac magnetic resonance imaging

Pretreatment group

Patients in pretreatment state

Other: Cardiac magnetic resonance imaging

Anthracycline-based chemotherapy (3 months)

Patients who received anthracycline-based chemotherapy 3 months ago

Other: Cardiac magnetic resonance imaging

Anthracycline-based chemotherapy (6 months)

Patients who received anthracycline-based chemotherapy 6 months ago

Other: Cardiac magnetic resonance imaging

Anthracycline-based chemotherapy (more than 1 year ago)

Patients who received anthracycline-based chemotherapy more than 1 year ago

Other: Cardiac magnetic resonance imaging

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

Interventions

Cardiac magnetic resonance imaging 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); Anthracycline-based chemotherapy (6 months); Anthracycline-based chemotherapy (more than 1 year ago); Control group; Other therapy group; Pretreatment group

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient with breast cancer

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 38329404 DERIVED

• 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.

  PMID: 32493217 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: December 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)