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

NCT02735746 | Completed FDA Device

• 1 other identifier: IIT2015-07-SHIAO-HIFIDELI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Breast Cancer; Mediastinum Lesion; Radiation Pneumonitis

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• 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

Study Arms (1)

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); Radiation: Cone Beam CT; Radiation: Low-dose Cinefluorography; Device: Pulmonary Function Tests

Interventions

4D Computed Tomography (CT) RADIATION

The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.

High fidelity functional lung imaging

Cone Beam CT RADIATION

Daily cone beam CT imaging at each radiation treatment visit, as part of standard care

High fidelity functional lung imaging

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.

Also known as: Fluoroscopic images

High fidelity functional lung imaging

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

High fidelity functional lung imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Radiation Pneumonitis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stephen Shiao, MD, PhD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 13, 2016
• Study Start: August 21, 2016
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)