NCT00577798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

December 19, 2007

Results QC Date

December 11, 2022

Last Update Submit

October 10, 2023

Conditions

Cardiac ToxicityChemotherapeutic Agent ToxicityLymphoma

Keywords

chemotherapeutic agent toxicitycardiac toxicitystage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromestage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomaadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomastage I adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomastage I adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomastage I grade 1 follicular lymphomastage III grade 1 follicular lymphomastage IV grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomastage I grade 2 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage I grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomanodal marginal zone B-cell lymphomasplenic marginal zone lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Observational

Only had observational arm

Procedure: contrast-enhanced magnetic resonance imaging

Interventions

contrast-enhanced magnetic resonance imagingPROCEDURE

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.

Observational

Eligibility Criteria

Age19 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, 68198-6805, United States

Location

Related Publications (4)

  • 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.

    PMID: 20622140BACKGROUND

  • 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.

    PMID: 22581073BACKGROUND

  • 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.

    PMID: 22578518BACKGROUND

  • 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.

    PMID: 22044862BACKGROUND

MeSH Terms

Conditions

CardiotoxicityLymphomaHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-CellLymphadenopathyNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease Attributes

Results Point of Contact

Title
Thomas Porter, MD
Organization
University of Nebraska Medical Center
trporter@unmc.edu
+1 (402) 559-8150

Study Officials

  • Thomas R Porter, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 20, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2010

Study Completion

February 1, 2013

Last Updated

November 3, 2023

Results First Posted

November 3, 2023

Record last verified: 2023-10

Locations

US(1)