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

Hodgkin Lymphoma Survivor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02106611
• Other study ID #: 14-017
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma Survivor
• Lymphoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the prevalence of cardiac injury	detected by cardiac MRI to that detected by stress echocardiography among a broadly representative cohort of Hodgkin lymphoma survivors.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center