Lung Cancer, Breast Cancer, Mediastinum Lesion, Radiation Pneumonitis
Conditions
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 description
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.
Interventions
RADIATIONLow-dose Cinefluorography
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.
DEVICEPulmonary Function Tests
Pulmonary Function Testing (PFT) gives global functional data for the lungs as a whole, but is relatively insensitive to early pathological changes. It involves taking very deep breaths and exhaling as forcefully as possible. Research PFTs will be conducted at 4 and 12-months post radiation therapy
RADIATION4D Computed Tomography (CT)
The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.
RADIATIONCone Beam CT
Daily cone beam CT imaging at each radiation treatment visit, as part of standard care
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years and older * Prospective subjects will have been referred to Radiation Oncology for treatment requiring the use of the Varian TrueBeam system, for radiation therapy of a cancer lesion in the chest wall, lung, breast, or mediastinum in which the radiation field will include a portion of lung * The subject is able to understand the risks, benefits, and possible alternatives to participation in the study, and is able to give both written and verbal voluntary informed consent
Exclusion criteria
* For any reason, including pregnancy, subject is considered by the Investigator to be an unsuitable candidate or is put at excess risk by the study procedures. * Significant existing lung disease, not related to cancer as determined by the PI's review of the patient's PFTs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | 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 | 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 ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | 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 expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | 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 inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | 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 expiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT | Baseline | — |
| A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT | Baseline | — |
| A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT | Baseline | — |
| A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT | Baseline | — |
| A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT | Baseline | — |
| A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT | Baseline | — |
| A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | 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. |
Secondary
| Measure | Time frame |
|---|---|
| FEV1/Forced vital capacity | At 12 months post radiation |
| Total lung capacity | At 12 months post radiation |
| Diffusing capacity for carbon monoxide | At 12 months post radiation |
| Forced expiratory volume 1 (FEV1) | At 12 months post radiation |
Countries
United States
Outcome results
None listed