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

Active, not recruiting

• Conditions: Hodgkin Lymphoma Survivor
• Interventions: Other: Clinical Assessment; Procedure: Stress cardiac MRI; Procedure: Stress echocardiogram

• Registration Number: NCT02106611
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 133

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hodgkin Lymphoma Survivor	Stress echocardiogram	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.
Hodgkin Lymphoma Survivor	Clinical Assessment	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.
Hodgkin Lymphoma Survivor	Stress cardiac MRI	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States