NCT04489758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

July 23, 2020

Last Update Submit

August 29, 2022

Conditions

Constrictive Bronchiolitis

Keywords

fluoroscopyX-ray velocimetry

Outcome Measures

Primary Outcomes (1)

  • X-ray velocimetry results

    Heterogeneity of ventilation as detected by X-ray velocimetry

    1 month

Study Arms (2)

Constrictive Bronchiolitis

EXPERIMENTAL

Veterans with surgical lung biopsy-proven constrictive bronchiolitis

Diagnostic Test: X-ray velocimetry analyzed by 4Dx XV Ventilation Analysis

Controls

ACTIVE COMPARATOR

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

Diagnostic Test: X-ray velocimetry analyzed by 4Dx XV Ventilation Analysis

Interventions

X-ray velocimetry analyzed by 4Dx XV Ventilation AnalysisDIAGNOSTIC_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.

Constrictive BronchiolitisControls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Constrictive bronchiolitis arm:
  • Biopsy demonstrating constrictive bronchiolitis
  • Prior CT Chest
  • years old
  • \< 1 pack year history of tobacco use
  • Control arm:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • King MS, Eisenberg R, Newman JH, Tolle JJ, Harrell FE Jr, Nian H, Ninan M, Lambright ES, Sheller JR, Johnson JE, Miller RF. Constrictive bronchiolitis in soldiers returning from Iraq and Afghanistan. N Engl J Med. 2011 Jul 21;365(3):222-30. doi: 10.1056/NEJMoa1101388.

    PMID: 21774710BACKGROUND

  • Richmond BW, Lester MG, Lui V, Dusting J, Raju S, Snell GI, Blackburn JB, Douglas K, Miller RF, Siddharthan T, Fouras A. X-ray velocimetry provides temporally and spatially-resolved biomarkers of lung ventilation in small airways disease. Respir Res. 2025 Jul 2;26(1):226. doi: 10.1186/s12931-025-03295-6.

    PMID: 40604808DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 4Dx XV Ventilation Analysis applied to fluoroscopic images
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pulmonary/Critical Care Medicine

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 28, 2020

Study Start

June 25, 2021

Primary Completion

May 27, 2022

Study Completion

May 27, 2022

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)