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Completed

NCT Number: NCT02735746

Novel 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.

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Key information

Conditions

Lung Cancer Breast Cancer Breast Diseases Breast Neoplasms Lung Diseases Lung Diseases, Interstitial Lung Injury Lung Neoplasms Mediastinum Lesion Neoplasms Neoplasms by Site Radiation Injuries Radiation Pneumonitis Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4D Computed Tomography (CT)

Radiation

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

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.

Other names: Fluoroscopic images

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

Primary outcomes

  1. A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT

    Time frame: Baseline

  2. A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT

    Time frame: Baseline

  3. A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT

    Time frame: Baseline

  4. A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT

    Time frame: Baseline

  5. A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT

    Time frame: Baseline

  6. A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT

    Time frame: Baseline

  7. A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT

    Time frame: During radiation therapy

    As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

  8. A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT

    Time frame: During radiation therapy

    As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

  9. A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT

    Time frame: During radiation therapy

    As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

  10. A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT

    Time frame: During radiation therapy

    As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

  11. A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT

    Time frame: During radiation therapy

    As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

  12. A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with cone beam CT

    Time frame: During radiation therapy

    As part of standard care, patients will have a cone beam CT on each day they receive radiation treatment. Treatment period varies.

Secondary outcomes

  1. Forced expiratory volume 1 (FEV1)

    Time frame: At 12 months post radiation

  2. FEV1/Forced vital capacity

    Time frame: At 12 months post radiation

  3. Total lung capacity

    Time frame: At 12 months post radiation

  4. Diffusing capacity for carbon monoxide

    Time frame: At 12 months post radiation

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: HFFLI

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2016
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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