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Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy

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ClinicalTrials.gov Identifier: NCT02404818
Recruitment Status : Active, not recruiting
First Posted : April 1, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.

Condition or disease Intervention/treatment
Hodgkin's Lymphoma Procedure: Cardiac Magnetic Resonance Imaging Procedure: Echocardiogram

Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation
Study Start Date : April 2015
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Survivors of Hodgkin's lymphoma
Cardiac Magnetic Resonance Imaging and Echocardiogram
Procedure: Cardiac Magnetic Resonance Imaging
A cardiac MRI will be performed.

Procedure: Echocardiogram
An echocardiogram will be performed for the following information: M-mode, two-dimensional, Doppler blood flow measurements, and longitudinal strain and strain rate imaging




Primary Outcome Measures :
  1. Cardiac Abnormalities As Measured By Cardiac MRI [ Time Frame: Day 1 ]
  2. Cardiac Abnormalities As Measured By Echocardiogram [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.
Criteria

Inclusion Criteria:

  • Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
  • Patient must be ≥ 18 years at time of consent.

Exclusion Criteria:

  • Pregnant women at time of Cardiac MRI
  • Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices)
  • Glomerular filtration rate (GFR) < 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404818


Locations
United States, Florida
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Health Proton Therapy Institute

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02404818     History of Changes
Other Study ID Numbers: UFPTI-1431-HL02
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Radiation
Cardiac
Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases