Clinical trial NCT02735746: Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
Official title: Novel High Fidelity Functional Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Breast Cancer
Mediastinum Lesion
Radiation Pneumonitis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
timeFrame: Baseline
measure: A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
timeFrame: Baseline
measure: A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
timeFrame: Baseline
measure: A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
timeFrame: Baseline
measure: A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
timeFrame: Baseline
measure: A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with 4D planning CT
timeFrame: Baseline
measure: A Pearson correlation of >0.579 between peak expiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT
timeFrame: During radiation therapy
measure: A Pearson correlation of >0.579 between peak inspiratory flow as measured by HFFLI analysis of cinefluorograph compared with cone beam CT
timeFrame: During radiation therapy
measure: A Pearson correlation of >0.579 between ventilation/local time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT
timeFrame: During radiation therapy
measure: A Pearson correlation of >0.579 between expiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT
timeFrame: During radiation therapy
measure: A Pearson correlation of >0.579 between inspiratory time constant as measured by HFFLI analysis of cinefluorograph compared with cone beam CT
timeFrame: During radiation therapy
measure: A Pearson correlation of >0.579 between tissue shear as measured by HFFLI analysis of cinefluorograph compared with cone beam CT
timeFrame: During radiation therapy
Secondary outcomes:
measure: Forced expiratory volume 1 (FEV1)
timeFrame: At 12 months post radiation
measure: FEV1/Forced vital capacity
timeFrame: At 12 months post radiation
measure: Total lung capacity
timeFrame: At 12 months post radiation
measure: Diffusing capacity for carbon monoxide
timeFrame: At 12 months post radiation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinal Medical Center
name: Stephen Shiao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: