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

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.

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Key information

Conditions

Cardiac Toxicity Blood Protein Disorders Burkitt Lymphoma Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Chemotherapeutic Agent Toxicity Chronic Disease DNA Virus Infections Disease Attributes Drug-Related Side Effects and Adverse Reactions Epstein-Barr Virus Infections Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Radiation Injuries Sezary Syndrome Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia Wounds and Injuries

Age range

19 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, 68198-6805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast-enhanced Magnetic Resonance Imaging

Procedure

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.

Primary outcomes

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

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.

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)

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2013
First posted: Dec 20, 2007
Registry last updated: Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed