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

Cedars-Sinai Medical Center

Status: Completed

Conditions: Mediastinum Lesion; Breast Cancer; Radiation Pneumonitis; Lung Cancer

Treatments: Device: Pulmonary Function Tests; Radiation: Cone Beam CT; Radiation: Low-dose Cinefluorography; Radiation: 4D Computed Tomography (CT)

Study type: Observational

Funder types: Other

Identifiers

NCT02735746

IIT2015-07-SHIAO-HIFIDELI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

High fidelity functional lung imaging

Description:

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.

Treatment:

Radiation: 4D Computed Tomography (CT)

Radiation: Low-dose Cinefluorography

Device: Pulmonary Function Tests

Radiation: Cone Beam CT