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

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ClinicalTrials.gov Identifier: NCT02735746
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Shiao, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment
Lung Cancer Breast Cancer Mediastinum Lesion Radiation Pneumonitis 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel High Fidelity Functional Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
Actual Study Start Date : August 21, 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 Name: 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





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735746


Contacts
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Contact: Stephen Shiao 310-423-2836 Stephen.Shiao@cshs.org
Contact: Karen Kearns 310-967-0692 Karen.Kearns@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Karen Kearns    310-967-0692    Karen.Kearns@cshs.org   
Principal Investigator: Stephen Shiao, MD, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Stephen Shiao, MD, PhD Cedars-Sinal Medical Center

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Responsible Party: Stephen Shiao, Assistant Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02735746    
Other Study ID Numbers: IIT2015-07-SHIAO-HIFIDELI
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Pneumonia
Radiation Pneumonitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries