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

September 3, 2020 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the selection criteria will be recruited from the breast medical oncology clinics at MSKCC.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: cardiac MRI with DWI
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.
Device: cardiac MRI with DWI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Andrew Plodkowski, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2014

Primary Completion (Actual)

September 2, 2020

Study Completion (Actual)

September 2, 2020

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-191

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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