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NCT02404818 Clinical Trial

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

Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02404818
Other study ID # UFPTI-1431-HL02
Secondary ID IRB201703302
Status Completed
Phase
First received
Last updated
Start date April 2015
Est. completion date April 14, 2021

Study information
Verified date June 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date April 14, 2021
Est. primary completion date April 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cardiac Magnetic Resonance Imaging
A cardiac MRI will be performed.
• 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

Locations
Country Name City State
United States University of Florida Health Proton Therapy Institute Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Abnormalities As Measured By Cardiac MRI Day 1
Primary Cardiac Abnormalities As Measured By Echocardiogram Day 1
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