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Trial record 94 of 1216 for:    "Hodgkin lymphoma"

Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors

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ClinicalTrials.gov Identifier: NCT02106611
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma associated heart disease compared to a stress echocardiogram. By doing both stress echocardiography and cardiac MRI, we will compare the ability of the two tests to detect heart disease.

Condition or disease Intervention/treatment
Hodgkin Lymphoma Survivor Other: Clinical Assessment Procedure: Stress cardiac MRI Procedure: Stress echocardiogram

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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hodgkin Lymphoma Survivor
This is a prospective cross-sectional study of 200 HL survivors whose treatment included mediastinal RT at initial diagnosis or relapse, and are at least 5 years from last HL treatment.
Other: Clinical Assessment
HL treatment will be determined by review of available medical records as archived at MSKCC. Recorded variables will include: (1) RT - field, fractional and cumulative dose, and duration; (2) chemotherapy - regimen, planned interval, dose per cycle, and cumulative dosages. Patients will also be asked to complete the FACT-LYM questionnaire and the FACIT Fatigue questionnaire.

Procedure: Stress cardiac MRI
Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.

Procedure: Stress echocardiogram
Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.




Primary Outcome Measures :
  1. compare the prevalence of cardiac injury [ Time Frame: 2 years ]
    detected by cardiac MRI to that detected by stress echocardiography among a broadly representative cohort of Hodgkin lymphoma survivors.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSKCC
Criteria

Inclusion Criteria:

  • Classical or nodular lymphocyte predominant HL treated at Memorial Sloan-Kettering Cancer Center.
  • Age ≥ 18 years
  • Treatment for HL that included mediastinal RT at initial diagnosis or relapse.
  • ≥ 5 years from last HL treatment.

Exclusion Criteria:

  • Primary HL diagnosis prior to 1980.
  • Additional mediastinal RT or subsequent cardiotoxic systemic therapy for secondary malignant neoplasm.
  • Known CAD/CHF (defined as documented myocardial infarction, cardiac revascularization, angiographic obstructive CAD, or decreased LV function [EF < 55%] during prior clinical care).
  • Contraindication to MRI (i.e. pacemakers, defibrillators, or aneurysm clips, or other implanted ferromagnetic objects), gadolinium (i.e. known hypersensitivity to gadolinium, advanced renal insufficiency as defined by glomerular filtration rate <30 ml/min/1.73m^2).
  • Contraindication to exercise stress testing other than the above (i.e. unstable angina or severe valvular stenosis).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106611


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Matthew Matasar, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02106611     History of Changes
Other Study ID Numbers: 14-017
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
MRI
stress echo
Clinical Assessment
14-017

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases