4DX for the Diagnosis of Constrictive Bronchiolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2022-05-27

Brief Summary

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Constrictive bronchiolitis is an uncommon lung disease that has been described in Veterans of conflicts in Iraq and Afghanistan. Although these Veterans have evidence of constrictive bronchiolitis on lung biopsies, non-invasive tests such as pulmonary function tests (PFTs) are often normal. This study will determine whether analysis of fluoroscopy images using the 4Dx XV Ventilation Analysis software developed by 4D Medical will be able to detect constrictive bronchiolitis in Veterans better than PFTs.

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Detailed Description

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Constrictive (or obliterative) bronchiolitis is a rare pulmonary disease characterized by subepithelial inflammatory and fibrotic narrowing of the bronchioles on histologic analysis, which often presents with nonspecific symptoms such as progressive dyspnea on exertion and nonproductive cough over weeks to months. Constrictive bronchiolitis may be triggered by autoimmune disease, chronic allograft rejection in lung transplant recipients, graft versus host disease in stem cell transplant recipients, viral illness, or inhaled toxins. Although pulmonary function tests (PFTs) may be helpful for the diagnosis of constrictive bronchiolitis, a study performed by King and colleagues in 2009 found that many Veterans with biopsy-proven constrictive bronchiolitis had normal PFTs. Thus, for these patients, more sensitive methods of noninvasive testing are needed.

4Dx XV Ventilation Analysis is a new imaging analysis algorithm which utilizes standard fluoroscopy to quantify ventilation with sufficient fidelity to identify regional differences. Fluoroscopic images of a single tidal breath are obtained at 5 distinct angles (direct AP, +/- 36 degrees, and +/- 72 degrees). Readouts from the 4Dx XV Ventilation Analysis include absolute value of total lung ventilation, heterogeneity of lung ventilation, a frequency distribution of lung ventilation as a line plot, and a regional map of lung ventilation. In addition, an expiratory time constant (time to exhale 63% of the tidal volume), heterogeneity of the expiratory time constant, frequency distribution of expiratory time constant as a line plot, and a regional map of expiratory time constant are also calculated. Pilot studies performed by 4D Medical show data generated by the 4Dx XV Ventilation Analysis software applied to fluoroscopy is reproducible in individuals with normal lung function and the heterogeneity index increases in individuals undergoing radiation therapy.

The investigators hypothesize that the 4Dx XV Ventilation Analysis program, when applied to standard fluoroscopic images, is more sensitive for the diagnosis of constrictive bronchiolitis than PFTs in Veterans with constrictive bronchiolitis. Specific metrics that will be evaluated with the software include ventilation heterogeneity and expiratory phase constants, among other metrics. Endpoints will be compared during tidal breathing and a full exhalation to residual volume from functional residual capacity.

Conditions

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Constrictive Bronchiolitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

4Dx XV Ventilation Analysis applied to fluoroscopic images

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Constrictive Bronchiolitis

Veterans with surgical lung biopsy-proven constrictive bronchiolitis

Group Type EXPERIMENTAL

X-ray velocimetry analyzed by 4Dx XV Ventilation Analysis

Intervention Type DIAGNOSTIC_TEST

Fluoroscopy will be performed for a complete tidal breath and full exhalation at 5 angles (AP, +/- 36 degrees from AP, and +/- 72 degrees from AP) while the patient's arms are raised overhead. 4Dx XV Ventilation Analysis software will be used to analyze these images. Both groups will also undergo pulmonary function testing and take a questionnaire regarding respiratory symptoms.

Controls

Control patients with minimal smoking history and no chronic lung disease or respiratory symptoms

Group Type ACTIVE_COMPARATOR

X-ray velocimetry analyzed by 4Dx XV Ventilation Analysis

Intervention Type DIAGNOSTIC_TEST

Fluoroscopy will be performed for a complete tidal breath and full exhalation at 5 angles (AP, +/- 36 degrees from AP, and +/- 72 degrees from AP) while the patient's arms are raised overhead. 4Dx XV Ventilation Analysis software will be used to analyze these images. Both groups will also undergo pulmonary function testing and take a questionnaire regarding respiratory symptoms.

Interventions

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X-ray velocimetry analyzed by 4Dx XV Ventilation Analysis

Fluoroscopy will be performed for a complete tidal breath and full exhalation at 5 angles (AP, +/- 36 degrees from AP, and +/- 72 degrees from AP) while the patient's arms are raised overhead. 4Dx XV Ventilation Analysis software will be used to analyze these images. Both groups will also undergo pulmonary function testing and take a questionnaire regarding respiratory symptoms.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Constrictive bronchiolitis arm:

* Biopsy demonstrating constrictive bronchiolitis
* Prior CT Chest
* 18-60 years old
* \< 1 pack year history of tobacco use

Control arm:

* 18-60 years old
* Prior CT Chest without evidence chronic lung disease as judged by a Pulmonologist
* No clinically significant dyspnea or functional limitations
* \< 1 pack year history of tobacco use

Exclusion Criteria

* Pregnancy (as determined by testing on the morning prior to fluoroscopy)
* Inability to undergo PFTs or fluoroscopy
* Inability to raise arms above a 90-degree angle

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No