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

University of Nebraska10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Toxicity Chemotherapeutic Agent Toxicity Lymphoma

Interventions

contrast-enhanced magnetic resonance imagingPROCEDURE

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). Participants will have already received doxorubicin hydrochloride as standard therapy when undergoing chemotherapy for non-Hogdkin's lymphoma and Hogdkin's lymphoma.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 120 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy

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)

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.

Data from ClinicalTrials.gov

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