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

June 9, 2022 updated by: University of Florida

UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5

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
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Health Proton Therapy Institute

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac Abnormalities As Measured By Cardiac MRI
Time Frame: Day 1
Day 1
Cardiac Abnormalities As Measured By Echocardiogram
Time Frame: Day 1
Day 1

Collaborators and Investigators

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

Sponsor

University of Florida

Investigators

  • Principal Investigator: Bradford S Hoppe, MD, MPH, University of Florida Health Proton Therapy Institute

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

April 1, 2015

Primary Completion (Actual)

April 14, 2021

Study Completion (Actual)

April 14, 2021

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI-1431-HL02
  • IRB201703302 (Other Identifier: UF IRB-03)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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