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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00577798
First received: December 19, 2007
Last updated: August 19, 2010
Last verified: August 2010

December 19, 2007
August 19, 2010
November 2007
December 2012   (final data collection date for primary outcome measure)
Change in myocardial function and structure [ Time Frame: cMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen. ] [ Designated as safety issue: No ]
Change in myocardial function and structure
Complete list of historical versions of study NCT00577798 on ClinicalTrials.gov Archive Site
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Cardiac Magnetic Resonance Imaging in Patients With Newly Diagnosed Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin
Cardiac MRI for Assessment of Cardiac Structure and Function Following Doxorubicin Based Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

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.

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.

Interventional
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Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
  • Cardiac Toxicity
  • Chemotherapeutic Agent Toxicity
  • Lymphoma
  • Drug: doxorubicin hydrochloride
    Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lyphoma and Hogdkin's lymphoma
  • Procedure: contrast-enhanced magnetic resonance imaging
    Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
Not Provided
December 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of non-Hodgkin lymphoma or Hodgkin lymphoma

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

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No pacemaker
  • No chronic kidney disease stages 3-5 (glomerular filtration rate < 60 mL/min)
  • Able to lie flat for 90 minutes
  • 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
  • Able to fulfill the requirements of the study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy
  • No prior radiotherapy to mantle or mediastinum
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577798
409-07, P30CA036727, UNMC-40907
No
Thomas Porter, M.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
University of Nebraska
National Cancer Institute (NCI)
Principal Investigator: Thomas R. Porter, M.D. University of Nebraska
University of Nebraska
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP