Clinical trial NCT02274480: Diffusion Weighted Imaging as a Biomarker for Detection of Chemotherapy Induced Cardiotoxicity
Official title: Diffusion Weighted Imaging as a Biomarker for Detection of Chemotherapy Induced Cardiotoxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy Induced Cardiotoxicity in Breast Cancer Patients
Keywords: MRI
Diffusion Weighted Imaging
14-191
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the selection criteria will be recruited from the breast medical oncology clinics at MSKCC.

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.

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

Primary outcomes:
measure: presence of edema
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew Plodkowski, MD
role: PRINCIPAL_INVESTIGATOR
References: