Functional Lung Imaging in Patients With Respiratory Compromise Undergoing Endobronchial Valve Placement

NCT05204875 | Unknown

• 1 other identifier: 269649
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchoscopic lung volume reduction (BLVR) using endobronchial valves is effective in improving quality of life in patients suffering from emphysema. BLVR treatment in advanced emphysema requires targeted segmental or sub-segmental placement of endobronchial valves (EBV) to achieve total lobar occlusion to induce effective lobar volume reduction. BLVR procedure success rate declines in patients with incomplete lobar fissure integrity due to the potential for collateral ventilation to circumvent EBV lobar occlusion. Current methods that assess lobar collateral ventilation as a correlate of fissure integrity are imperfect, resulting in a significant percentage of patients having equivocal assessment, leading to suboptimal selection of patients and potential for inappropriate selection of patients for BLVR. Additionally, methods used to select the target lobe for EBV placement predominately rely on the extent of emphysematous destruction. There is also a need to select based on the extent of physiological disturbance at the lobar level. Distribution of ventilation or regional ventilation heterogeneity may be associated with collateral ventilation. Therefore, in this study we wish to quantify lobar distribution of ventilation and ventilation heterogeneity in patients undergoing investigation for BLVR to determine the additive contribution of functional lung imaging for assessing lobar physiological derangement and suitability for EBV treatment.

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• The objective of the current investigation is to determine whether XV technology can assist in determining lobar selection, indicators of success, or response-related clinical outcomes with BLVR.

  Functional lung imaging analysis in endobronchial valve placement

  functional lung imaging and software analysis will be available after the procedure

Study Arms (1)

Functional lung imaging

Assess the applicability of XV ventilation distribution and heterogeneity for BLVR candidate screening compared to conventional tools of quantitative HRCT and ventilation perfusion scanning.

Radiation: X-ray Velocimetry

Interventions

X-ray Velocimetry RADIATION

X-ray Velocimetry (XV) technology images the motion of the lungs, determines airway volumes and measures regional lung ventilation during spontaneous breathing.

Functional lung imaging

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD undergoing bronchoscopic lung volume reduction

You may qualify if:

• Emphysema
• Undergoing evaluation and planned treatment with BLVR
• Adults, 40 years of age and older
• Consents to functional lung imaging evaluation
• Access to previous chest CT as part of the clinical workup for BLVR

You may not qualify if:

• Known contraindication to BLVR
• Currently receiving mechanical ventilation, intensive or other critical care
• Pregnant women
• Contraindication to ionizing radiation

Sponsors & Collaborators

• Temple University: lead
• Respiratory Compromise Institute: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerard Criner, MD

CONTACT

215-707-8113; Gerard.criner@tuhs.temple.edu

Michael Jacobs, PharmD

CONTACT

215-707-2242; Michael.jacobs@temple.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 24, 2022
• Study Start: July 5, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

US (1)