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

NCT ID: NCT00577798

Last Updated: 2023-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2013-02-01

Brief Summary

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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

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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.

Conditions

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Cardiac Toxicity Chemotherapeutic Agent Toxicity Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Only had observational arm

contrast-enhanced magnetic resonance imaging

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas R Porter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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Lightfoot JC, D'Agostino RB Jr, Hamilton CA, Jordan J, Torti FM, Kock ND, Jordan J, Workman S, Hundley WG. Novel approach to early detection of doxorubicin cardiotoxicity by gadolinium-enhanced cardiovascular magnetic resonance imaging in an experimental model. Circ Cardiovasc Imaging. 2010 Sep;3(5):550-8. doi: 10.1161/CIRCIMAGING.109.918540. Epub 2010 Jul 9.

Reference Type BACKGROUND
PMID: 20622140 (View on PubMed)

Kutty S, Rangamani S, Venkataraman J, Li L, Schuster A, Fletcher SE, Danford DA, Beerbaum P. Reduced global longitudinal and radial strain with normal left ventricular ejection fraction late after effective repair of aortic coarctation: a CMR feature tracking study. Int J Cardiovasc Imaging. 2013 Jan;29(1):141-50. doi: 10.1007/s10554-012-0061-1. Epub 2012 May 12.

Reference Type BACKGROUND
PMID: 22581073 (View on PubMed)

Poterucha JT, Kutty S, Lindquist RK, Li L, Eidem BW. Changes in left ventricular longitudinal strain with anthracycline chemotherapy in adolescents precede subsequent decreased left ventricular ejection fraction. J Am Soc Echocardiogr. 2012 Jul;25(7):733-40. doi: 10.1016/j.echo.2012.04.007. Epub 2012 May 10.

Reference Type BACKGROUND
PMID: 22578518 (View on PubMed)

Sipola P, Vanninen E, Jantunen E, Nousiainen T, Kiviniemi M, Hartikainen J, Kuittinen T. A prospective comparison of cardiac magnetic resonance imaging and radionuclide ventriculography in the assessment of cardiac function in patients treated with anthracycline-based chemotherapy. Nucl Med Commun. 2012 Jan;33(1):51-9. doi: 10.1097/MNM.0b013e32834bfec4.

Reference Type BACKGROUND
PMID: 22044862 (View on PubMed)

Other Identifiers

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P30CA036727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UNMC-40907

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0409-07-FB

Identifier Type: -

Identifier Source: org_study_id

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