MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:22 - Any
Updated:4/4/2019
Start Date:January 2013
End Date:March 2021

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Early Imaging Detection of Cardiovascular Injury After Cancer

This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage
in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help
doctors predict whether patients will have heart damage caused by chemotherapy in patients
with cancer receiving chemotherapy.

PRIMARY OBJECTIVES:

I. To design an automated MRI hardware/software platform for measuring and reporting left
ventricular (LV) function (volumes, strain, and ejection fraction [EF]), T1 myocardial
signal, and aortic pulse wave velocity (PWV).

II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes
in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic
PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.

OUTLINE:

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline,
3 months, and 24 months.

Inclusion Criteria:

- Receiving >= 350 mg/m^2 of Anth-bC therapy, or a combination of Anth-bC (>= 250
mg/m^2) and subsequent paclitaxel or Herceptin

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices,
or other implanted electronic devices

- Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal

- Allergy to gadolinium or other severe drug allergies

- Unstable angina

- Significant ventricular arrhythmias (> 20 premature ventricular contractions
[PVCs]/minute due to gating difficulty)

- Acute myocardial infarction within 28 days

- Atrial fibrillation with uncontrolled ventricular response

- Moderate or severe aortic stenosis

- Claustrophobia

- Congestive heart failure (New York Heart Association [NYHA] class III or IV)

- Significant valvular disease, or significant pulmonary disease requiring supplemental
oxygen therapy

- Participants unwilling to complete the protocol (24 month duration)

- Women who are pregnant

- Patients unable or unwilling to provide informed consent
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Principal Investigator: William G. Hundley
Phone: 336-716-6125
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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mi
from
Winston-Salem, NC
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