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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02404818
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Duration (Months): 72.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
Hodgkin's Lymphoma	Procedure: Cardiac Magnetic Resonance Imaging; Procedure: Echocardiogram

Study Design

• Study Type: Observational
• Anticipated 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: Apr 1, 2015
• Actual Primary Completion Date: Apr 14, 2021
• Actual Study Completion Date: Apr 14, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cardiac Abnormalities As Measured By Cardiac MRI [Day 1]

2. Cardiac Abnormalities As Measured By Echocardiogram [Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02404818
• Other Study ID Numbers: UFPTI-1431-HL02; IRB201703302
• First Posted: Apr 1, 2015
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• 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

Study Results

No Results Posted as of Jun 10, 2022