Radiation Induced Cardiopulmonary Injury in Humans

UNC Lineberger Comprehensive Cancer Center

Status: Terminated

Conditions: Thoracic; Pulmonary Injury; Heart Injuries

Treatments: Procedure: SPECT Lung Perfusion Scan; Procedure: Pulmonary Function Tests; Procedure: SPECT Heart Perfusion Scan

Study type: Observational

Funder types: Other

Identifiers

NCT02259452

LCCC0808

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.