NCT02106611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

11.9 years

First QC Date

April 3, 2014

Last Update Submit

February 9, 2026

Conditions

Keywords

MRIstress echoClinical Assessment14-017

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 AssessmentProcedure: Stress cardiac MRIProcedure: Stress echocardiogram

Interventions

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.

Hodgkin Lymphoma Survivor

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.

Hodgkin Lymphoma Survivor

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.

Hodgkin Lymphoma Survivor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSKCC

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Study Officials

  • Alison Moskowitz, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 8, 2014

Study Start

April 1, 2014

Primary Completion

February 6, 2026

Study Completion

February 6, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations