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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lung Cancer; Radiation Pneumonitis; Mediastinum Lesion
• Intervention / Treatment: Radiation: 4D Computed Tomography (CT); Radiation: Cone Beam CT; Radiation: Low-dose Cinefluorography; Device: Pulmonary Function Tests

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Radiation: 4D Computed Tomography (CT); The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.; Radiation: Cone Beam CT; Daily cone beam CT imaging at each radiation treatment visit, as part of standard care; Radiation: Low-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.; Other Names: Fluoroscopic images; Device: Pulmonary 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Forced expiratory volume 1 (FEV1)	At 12 months post radiation
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Stephen Shiao, MD, PhD, Cedars-Sinal Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2016
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimated): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Radiation Injuries; Lung Injury; Pneumonia; Radiation Pneumonitis
• Other Study ID Numbers: IIT2015-07-SHIAO-HIFIDELI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No