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

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT00577798

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Toxicity Chemotherapeutic Agent Toxicity Lymphoma	Drug: doxorubicin hydrochloride Procedure: contrast-enhanced magnetic resonance imaging	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Observational Only had observational arm	Drug: doxorubicin hydrochloride Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lyphoma and Hogdkin's lymphoma 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).

Arm

Intervention/Treatment

No Intervention: Observational

Only had observational arm

Drug: doxorubicin hydrochloride

Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lyphoma and Hogdkin's lymphoma

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).

Outcome Measures

Primary Outcome Measures

Change in myocardial function and structure [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

Criteria

Ages Eligible for Study:

19 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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