Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT05204875

Conditions

Emphysema

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

X-ray Velocimetry

Study Details

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

Study ID

NCT05204875

Start date

Jul 5, 2022

Status verified date

Oct, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Nov, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

X-ray Velocimetry

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

Primary outcome measure

  • 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. [ Time Frame: functional lung imaging and software analysis will be available after the procedure ]

Central Contacts and Locations

Central contacts

Locations

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Gerard J Criner, MD

More Information

Sponsor

Temple University

Last update posted

Oct 24, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2022-10-24.