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MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT01719562
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Toxicity Malignant Neoplasm Procedure: magnetic resonance imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Imaging Detection of Cardiovascular Injury After Cancer
Study Start Date : January 2013
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719562


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William Hundley Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01719562     History of Changes
Other Study ID Numbers: IRB00020968
NCI-2012-01613 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU 99112 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries