Early Imaging Detection of Cardiovascular Injury After Cancer
22 Years
N/A
Both
Cardiac Toxicity, Malignant Neoplasm
Trial Information
Early Imaging Detection of Cardiovascular Injury After Cancer
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 (6 month duration)
- Women who are pregnant
- Patients unable or unwilling to provide informed consent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To correlate results of an automated MRI hardware/software platform for measuring left ventricular (LV) function with manual results.
Outcome Description:
For the automation to be considered useful it should correlate highly with the manual results, exhibit a similar mean value and overall variability. 95% confidence intervals (CIs) of the difference between measures will be constructed and the upper and lower bounds of these intervals will be examined. The final diagnostic we will perform is to run F-tests to determine whether the variability from each measure is the same or different. 95% CIs will be examined for the ratio of the variance.
Outcome Time Frame:
Up to 24 months
Safety Issue:
No
Principal Investigator
William Hundley
Investigator Role:
Principal Investigator
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 99112
NCT ID:
NCT01719562
Start Date:
January 2013
Completion Date:
Related Keywords:
- Cardiac Toxicity
- Malignant Neoplasm
- Neoplasms
Name | Location |
|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
