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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577798
• Other study ID #: 0409-07-FB
• Secondary ID: P30CA036727UNMC-
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: February 1, 2013

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 1, 2013
• Est. primary completion date: March 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Toxicity
• Cardiotoxicity
• Chemotherapeutic Agent Toxicity
• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Eppley Cancer Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy	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.