- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00577798
Cardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198-6805
- University of Nebraska Medical Center, Eppley Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Observational
Only had observational arm
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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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas R Porter, MD, University of Nebraska
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Nucl Med Commun. 2013 Jul;34(7):726. Petri, Sipola [corrected to Sipola, Petri]; Esko, Vanninen [corrected to Vanninen, Esko]; Esa, Jantunen [corrected to Jantunen, Esa]; Tapio, Nousiainen [corrected to Nousiainen, Tapio]; Mikko, Kiviniemi [corrected to Kiviniemi, Mikko]; Juha, Hartikainen [c.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- cutaneous B-cell non-Hodgkin lymphoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- stage I mantle cell lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage II mycosis fungoides/Sezary syndrome
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
- chemotherapeutic agent toxicity
- cardiac toxicity
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Wounds and Injuries
- Drug-Related Side Effects and Adverse Reactions
- Radiation Injuries
- Lymphoma
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Cardiotoxicity
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
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
Studies a U.S. FDA-regulated device product
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