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

NCT ID: NCT02106611

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2026-04-30

Brief Summary

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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

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Conditions

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Hodgkin Lymphoma Survivor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Clinical Assessment

Intervention Type OTHER

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.

Stress cardiac MRI

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Moskowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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14-017

Identifier Type: -

Identifier Source: org_study_id

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