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Cardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin

Completed
Conditions
Chemotherapeutic Agent Toxicity
Lymphoma
Cardiac Toxicity
Interventions
Procedure: contrast-enhanced magnetic resonance imaging
Registration Number
NCT00577798
Lead Sponsor
University of Nebraska
Brief Summary

RATIONALE: Diagnostic procedures, such as cardiac magnetic resonance imaging, may help doctors detect early changes in the heart caused by chemotherapy.

PURPOSE: This clinical trial is studying how well cardiac magnetic resonance imaging works in patients with newly diagnosed non-Hodgkin lymphoma or Hodgkin lymphoma receiving doxorubicin.

Detailed Description

OBJECTIVES:

* To determine whether early myocardial structural and functional changes can be detected using cardiac MRI in patients with newly diagnosed non-Hodgkin lymphoma or Hodgkin lymphoma receiving doxorubicin hydrochloride-based chemotherapy.

OUTLINE: Patients undergo cardiac MRI with gadolinium contrast prior to initiation of doxorubicin hydrochloride-based chemotherapy and 3 months after completion of six courses of chemotherapy for non-Hodgkin lymphoma and twelve courses of chemotherapy for Hodgkin lymphoma.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria
  • Diagnosis of non-Hodgkin lymphoma or Hodgkin lymphoma

    o Newly diagnosed disease

  • Planning to receive doxorubicin hydrochloride-based chemotherapy solely at the University of Nebraska Medical Center

  • Fertile patients must use effective contraception

  • Able to lie flat for 90 minutes

  • Able to fulfill the requirements of the study

Exclusion Criteria
  • Not pregnant or nursing
  • No pacemaker
  • No chronic kidney disease stages 3-5 (glomerular filtration rate < 60 mL/min)
  • No metallic foreign body not approved for MRI
  • No known hypersensitivity to gadolinium contrast or other required drugs in the study
  • No comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this study
  • No prior chemotherapy
  • No prior radiotherapy to mantle or mediastinum

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Observationalcontrast-enhanced magnetic resonance imagingOnly had observational arm
Primary Outcome Measures
NameTimeMethod
Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin ChemotherapycMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen.

A reduction of 10% in left ventricular ejection fraction (LVEF) between the two cMRI studies was considered a subclinical functional event. New or progressive myocardial delayed enhancement within ≥1 segment was deemed as a subclinical structural event. Global left ventricle (LV) radial, circumferential, and longitudinal strain data for each patient were compared between cMRI-1 and cMRI-2.

The study had a fixed endpoint (3 months post-treatment)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Nebraska Medical Center, Eppley Cancer Center

🇺🇸

Omaha, Nebraska, United States

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