Overview

This trial is active, not recruiting.

Conditions cardiac toxicity, chemotherapeutic agent toxicity, lymphoma
Treatments doxorubicin hydrochloride, contrast-enhanced magnetic resonance imaging
Sponsor University of Nebraska
Collaborator National Cancer Institute (NCI)
Start date November 2007
End date December 2012
Trial size 15 participants
Trial identifier NCT00577798, 409-07, P30CA036727, UNMC-40907

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking single blind (investigator)
Primary purpose diagnostic

Primary Outcomes

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.

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Cardiac MRI for Assessment of Cardiac Structure and Function Following Doxorubicin Based Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
Principal investigator Thomas R. Porter, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by University of Nebraska.