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Completed

NCT Number: NCT02274480

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Westchester, Harrison, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac MRI with DWI

Device

Primary outcomes

  1. presence of edema

    Time frame: 1 year

    associated with cardiotoxicity as visualized on DWI by the attending cardiac imagers we may explore the association of the presence of edema on DWI with a drop in LVEF > 10% using exact logistic regression

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2014
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.