Breast Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

28

Study ID:

NCT02274480

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 2 Locations for this study

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Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

28

Study ID:

NCT02274480

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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