Diffusion Weighted Imaging as a Biomarker for Detection of Chemotherapy Induced Cardiotoxicity

NCT ID: NCT02274480

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-22
• Study Completion Date: 2020-09-02

Brief Summary

The goal of this study is to see if a special type of heart scan called a diffusion weighted magnetic resonance imaging (DW-MRI) that uses extra measurements, can be used to find early signs of heart damage from chemotherapy.

Detailed Description

This prospective single institutional pilot study will enroll breast cancer patients who develop cardiotoxicity while on anthracycline and anti-HER2 therapy . The control group will be composed of patients on similar anthracycline therapy and dose but without a decline in LVEF on Cardiac MRI (CMR). Clinic visits with monitoring for cardiotoxicity occur as part of standard of care after therapy initiation. The study and control group will be composed of 15 patients each. At the discretion of the treating physician, patients will be recruited from the Breast Medical Oncology Service.

Conditions

Chemotherapy Induced Cardiotoxicity in Breast Cancer Patients

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast cancer patients with cardiotoxicity

Each patient will undergo a cardiac MRI with DWI. The standard of care in patients with declining LVEF is a cardiac MRI. For this study, those patients will also have the added DWI sequence. For patients who are not already scheduled for a cardiac MRI by their referring physician, and therefore do not have an upcoming standard of care cardiac MRI, a research cardiac MRI with DWI will be added. They will not be charged for the DW-MRI of the heart or any additional images taken as part of that scan. Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn and replaced in the study. After their cardiac MRI, their participation in the study is complete.

cardiac MRI with DWI

Intervention Type: DEVICE

Breast cancer patients without cardiotoxicity

Each patient will undergo a cardiac MRI with DWI. The standard of care in patients with declining LVEF is a cardiac MRI. For this study, those patients will also have the added DWI sequence. For patients who are not already scheduled for a cardiac MRI by their referring physician, and therefore do not have an upcoming standard of care cardiac MRI, a research cardiac MRI with DWI will be added. They will not be charged for the DW-MRI of the heart or any additional images taken as part of that scan. Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn and replaced in the study. After their cardiac MRI, their participation in the study is complete.

cardiac MRI with DWI

Intervention Type: DEVICE

Interventions

cardiac MRI with DWI

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥18 years of age on the day of signing the informed consent.
• Diagnosis of HER2+ breast cancer

• History of anthracycline therapy and antiHER2 treatment
• For subjects with decrease in LVEF: Recent (within 12 weeks) drop in LVEF ≥10% on echocardiogram from baseline and confirmed by cardiac MRI for the study population. If the drop in EF is not confirmed on MRI, the subject will be removed and placed into the control group.

For control group: Less than a 10% change in EF from baseline for the control population confirmed on echocardiogram and cardiac MRI. If no change in EF is not confirmed on MRI, the subject will be removed and placed into the study group if the change in EF is equal to or greater than 10%. Note: Male breast cancer patients are uncommon and are not expected to be included in this study, however if they meet the above criteria, they will not be excluded.

Exclusion Criteria

• Prior myocardial infarction
• Prior surgical or percutaneous coronary revascularization
• Pregnant or lactating patients
• Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of breast cancer cannot give valid informed consent
• Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc. MRI eligibility will be determined on the day of consent with the MRI questionnaire.
• Patients with metallic implants or device in the chest that might distort local magnetic field and compromise quality of MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Plodkowski, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-191

Identifier Type: -

Identifier Source: org_study_id