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

October 10, 2023 updated by: University of Nebraska

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-6805
        • University of Nebraska Medical Center, Eppley Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years and above were eligible if they had a new diagnosis (World Health Organization classification) of Non-Hodgkin Lymphoma who planned to undergo doxorubicin-based chemotherapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Only had observational arm
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). Participants will have already received doxorubicin hydrochloride as standard therapy when undergoing chemotherapy for non-Hogdkin's lymphoma and Hogdkin's lymphoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
cMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Thomas R Porter, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimated)

December 20, 2007

Study Record Updates

Last Update Posted (Actual)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0409-07-FB
  • P30CA036727 (U.S. NIH Grant/Contract)
  • UNMC-40907 (Other Grant/Funding Number: University of Nebraska Medical Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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