4D Medical X-ray Velocimetry for Bronchoscopic Lung Volume Reduction Targeting

Copd Clinical Trial

Official title:

4DXV for Targeting in Bronchoscopic Lung Volume Reduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04786171
• Other study ID #: 12345678910
• Status: Recruiting
• Start date: January 7, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: Michael Lester
• Phone: 2566830228
• Email: michael.g.lester[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will investigate the utility of 4D Medical's X-ray Velocimetry (XV) imaging analysis software for the detection of hyperinflation, and compare endobronchial valve placement outcomes with predictive indices obtained utilizing this technique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• CT chest and PFTs within the last two years
• Age over 18
• COPD with emphysema
• Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 - 4 classification OR modified Medical Research Council (mMRC) score of 2 or greater.

Exclusion Criteria:

• Pregnancy
• Presence of an additional pulmonary disease beyond COPD
• Inability to raise arms above 90 degrees as required for fluoroscopy

Related Conditions & MeSH terms

• Copd
• Emphysema
• Hyperinflation

Intervention

Diagnostic Test:
• 4D X-ray Velocimetry
X-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	American Thoracic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of residual volume over functional residual capacity by 4DXV	We will compare an XV hyperinflation index to traditional pulmonary function tests (PFTs) and outcomes	6 months
Primary	Expiratory Time Constants vs Fissure Completeness	We will examine the correlation between lobar expiratory time constants and fissure completeness by StratX	1 year
Secondary	Improvement in Saint George Respiratory Questionnaire (SGRQ)	We will compare SGRQs pre and post valve placement to hyperinflative indices by 4D XV	1 year