Radiation Induced Cardiopulmonary Injury in Humans

Terminated

• Conditions: Heart Injuries; Pulmonary Injury; Thoracic

• Registration Number: NCT02259452
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-08
• Primary Completion: 2018-04-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

1. Age ≥ 18 years
2. Patients who are to receive 3D-planned RT for tumor within and around the thorax.
3. Patients receiving incidental RT to portions of the heart are eligible.
4. Estimated minimum expected life expectancy of one year
5. Able to undergo the required study-related tests for regional lung injury and regional heart injury
6. 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.
7. Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Regional Heart Function	Up to 4 years post CRT
Changes in Regional Lung Function	Up to 4 years post CRT
Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes	Up to 4 years post CRT

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology; 🇺🇸 Chapel Hill, North Carolina, United States