Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Cancer, Cancer, Pneumonia
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:August 21, 2016
End Date:April 2020
Contact:Stephen Shiao
Email:Stephen.Shiao@cshs.org
Phone:310-423-2836

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Novel High Fidelity Functional Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis

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.

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.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Stephen Shiao, MD, PhD
Phone: 310-967-4376
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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