Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fidelity functional lung imaging | High fidelity functional lung imaging (HFFLI) is an improved method of measuring pulmonary function by analyzing 3-Dimensional (3D) motion. Using this technique, we are able to detect and localize pathological changes in the lung with sub-segmental resolution. The approach uses a unique cross-correlation analysis and non-linear optimization to reconstruct lung tissue motion from a small number of standard projections. All participants will undergo standard 4D Computed Tomography (CT), standard Cone Beam CT, research Low-dose Cinefluorography, and additional research Pulmonary Function Tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4D Computed Tomography (CT) | Radiation | The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies. | During radiation therapy |
| A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume 1 (FEV1) | At 12 months post radiation | |
| FEV1/Forced vital capacity | At 12 months post radiation | |
| Total lung capacity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults over the age of 18, referred to Radiation Oncology for treatment requiring the use of the Varian TrueBeam system for radiation therapy of a cancer lesion in the chest.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Shiao, MD, PhD | Cedars-Sinal Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cone Beam CT | Radiation | Daily cone beam CT imaging at each radiation treatment visit, as part of standard care |
|
| Low-dose Cinefluorography | Radiation | 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. |
|
|
| Pulmonary Function Tests | Device | 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 |
|
As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.
| During radiation therapy |
| A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies. | During radiation therapy |
| A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies. | During radiation therapy |
| A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies. | During radiation therapy |
| A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with cone beam CT | As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies. | During radiation therapy |
| At 12 months post radiation |
| Diffusing capacity for carbon monoxide | At 12 months post radiation |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D017564 | Radiation Pneumonitis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017563 | Lung Diseases, Interstitial |
| D055370 | Lung Injury |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided