Cardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin
- Conditions
- Chemotherapeutic Agent ToxicityLymphomaCardiac 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
-
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
- 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
Group Intervention Description Observational contrast-enhanced magnetic resonance imaging Only had observational arm
- Primary Outcome Measures
Name Time Method Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy cMRI 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
Name Time Method
Trial Locations
- Locations (1)
University of Nebraska Medical Center, Eppley Cancer Center
🇺🇸Omaha, Nebraska, United States