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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02106611

Collaborator

Weill Medical College of Cornell University (Other)

133

Enrollment

Location

108

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Hodgkin Lymphoma Survivor	Other: Clinical Assessment Procedure: Stress cardiac MRI Procedure: Stress echocardiogram

Study Design

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 :

Apr 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

compare the prevalence of cardiac injury [2 years]
detected by cardiac MRI to that detected by stress echocardiography among a broadly representative cohort of Hodgkin lymphoma survivors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).