MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01719562
First received: October 11, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Toxicity
Malignant Neoplasm
Procedure: magnetic resonance imaging
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Imaging Detection of Cardiovascular Injury After Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • To correlate results of an automated MRI hardware/software platform for measuring left ventricular (LV) function with manual results. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • To test the ability of the pre- to post-anthracycline-based chemotherapy (Anth-bC) changes in our MRI platform generated measures of LV function to predict pre- to 24 month post-Anth-bC differences in LV function. [ Time Frame: From baseline to 24 months ] [ Designated as safety issue: No ]
    Each patient is individually categorized as either having a persistent CV worsening or not depending on whether they exhibit a 20% worsening of their outcome by 3 months and that level of worsening persists to 24 months. We will examine paired t-tests for each time point for each measure to test whether measures are significantly worse at each time point. We will fit longitudinal models that examine all three time points (baseline, 3 and 24 months) simultaneously to determine whether there is a linear (or some other) function that can describe the decline in these subclinical CV MRI measures.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (MRI)
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Procedure: magnetic resonance imaging
Undergo MRI scans
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719562

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: William G. Hundley    336-716-6125    ghundley@wfubmc.edu   
Principal Investigator: William G. Hundley         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: William Hundley Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01719562     History of Changes
Other Study ID Numbers: CCCWFU 99112, NCI-2012-01613, P30CA012197
Study First Received: October 11, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014