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

December 27, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MSKCC

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Alison Moskowitz, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimated)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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