Radiation Induced Cardiopulmonary Injury in Humans

Stopped early

Conditions studied: Thoracic, Pulmonary Injury, Heart Injuries

In brief

The purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and predict RT-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT lung and heart assessments to better understand RT-induced regional heart/lung changes.

Key facts

Study ID

NCT02259452

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

91

Starts

2008-06-01

Last updated by the study team

2020-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Patients who are to receive 3D-planned RT for tumor within and around the thorax.
• Patients receiving incidental RT to portions of the heart are eligible.
• Estimated minimum expected life expectancy of one year
• Able to undergo the required study-related tests for regional lung injury and regional heart injury
• Patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study.
• Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.

You may not qualify if…

• Patients who are anticipated to have thoracic surgery post-RT are ineligible.
• Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function
• Pregnant or nursing women.

Where it is running

• University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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