- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02735746
Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis (HFFLI)
March 21, 2024 updated by: Stephen Shiao, Cedars-Sinai Medical Center
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
Recruiting
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephen Shiao
- Phone Number: 310-423-2836
- Email: Stephen.Shiao@cshs.org
Study Contact Backup
- Name: Karen Kearns
- Phone Number: 310-967-0692
- Email: Karen.Kearns@cshs.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
-
Contact:
- Karen Kearns
- Phone Number: 310-967-0692
- Email: Karen.Kearns@cshs.org
-
Principal Investigator:
- Stephen Shiao, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
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.
|
The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.
Daily cone beam CT imaging at each radiation treatment visit, as part of standard care
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:
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
Time Frame: Baseline
|
Baseline
|
|
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
|
Baseline
|
|
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
|
Baseline
|
|
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
|
Baseline
|
|
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
|
Baseline
|
|
A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
Time Frame: Baseline
|
Baseline
|
|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
During radiation therapy
|
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.
|
During radiation therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume 1 (FEV1)
Time Frame: At 12 months post radiation
|
At 12 months post radiation
|
FEV1/Forced vital capacity
Time Frame: At 12 months post radiation
|
At 12 months post radiation
|
Total lung capacity
Time Frame: At 12 months post radiation
|
At 12 months post radiation
|
Diffusing capacity for carbon monoxide
Time Frame: At 12 months post radiation
|
At 12 months post radiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Shiao, MD, PhD, Cedars-Sinal Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2016
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
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)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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