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

Breast Cancer Clinical Trial

— HFFLI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02735746
• Other study ID #: IIT2015-07-SHIAO-HIFIDELI
• Status: Recruiting
• Start date: August 21, 2016
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Cedars-Sinai Medical Center
• Contact: Stephen Shiao
• Phone: 310-423-2836
• Email: Stephen.Shiao[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Mediastinum Lesion
• Pneumonia
• Radiation Pneumonitis

Intervention

Radiation:
• 4D Computed Tomography (CT)
The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.
• Cone Beam CT
Daily cone beam CT imaging at each radiation treatment visit, as part of standard care
• 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.

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT		Baseline
Primary	A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT		Baseline
Primary	A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT		Baseline
Primary	A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT		Baseline
Primary	A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT		Baseline
Primary	A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT		Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Forced expiratory volume 1 (FEV1)		At 12 months post radiation
Secondary	FEV1/Forced vital capacity		At 12 months post radiation
Secondary	Total lung capacity		At 12 months post radiation
Secondary	Diffusing capacity for carbon monoxide		At 12 months post radiation