Clinical Trial: Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Novel High Fidelity Functional Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
Brief Summary: The purpose of this study is to to compare lung function data generated by applying High Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic images of the lungs breathing to determine whether different modalities of imaging provide similar data on lung movement and function. HFFLI may detect changes in lung function in patients undergoing External Beam Radiotherapy for cancer.
Detailed Summary: This study is designed to test a novel technology to examine early changes in the lung in hopes of identifying patients who may be at risk for radiation pneumonitis. Eligible subjects will undergo standard of care treatment with the use of the Varian TrueBeam system for radiation therapy of a cancer lesion in the chest. The imaging data acquired as part of usual standard of care for these patients is a pre-treatment 4D planning CT scan, and a daily cone beam CT at each radiation treatment visit. We will also obtain a series of images consisting of five six-second cinefluorographs (real time fluoroscopic movies, for a total each time of 30 seconds of fluoroscopy) of the lungs while the subject is breathing, each at precisely measured angles to the subject, on 4 different occasions. This study will compare lung function data generated by applying High Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic images of the lungs breathing to determine the degree of correlation between data generated from different imaging modalities. The study is open to adults over the age of 18, at any stage of cancer.
Sponsor: Cedars-Sinai Medical Center
Current Primary Outcome:
- A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT [ Time Frame: Baseline ]
- A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT [ Time Frame: Baseline ]
- A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT [ Time Frame: Baseline ]
- A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT [ Time Frame: Baseline ]
- A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT [ Time Frame: Baseline ]
- A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT [ Time Frame: Baseline ]
- A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT [ Time Frame: During radiation therapy ]As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.
- A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT [ Time Frame: D
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Forced expiratory volume 1 (FEV1) [ Time Frame: At 12 months post radiation ]
- FEV1/Forced vital capacity [ Time Frame: At 12 months post radiation ]
- Total lung capacity [ Time Frame: At 12 months post radiation ]
- Diffusing capacity for carbon monoxide [ Time Frame: At 12 months post radiation ]
Original Secondary Outcome: Same as current
Information By: Cedars-Sinai Medical Center
Dates:
Date Received: April 7, 2016
Date Started: August 2016
Date Completion: April 2020
Last Updated: August 31, 2016
Last Verified: August 2016
