Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05204875 |
| Other study ID # |
269649 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2022 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Temple University |
| Contact |
Gerard Criner, MD |
| Phone |
215-707-8113 |
| Email |
Gerard.criner[@]tuhs.temple.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Approach: A novel functional lung imaging, X-ray Velocimetry (XV) technology images the
motion of the lungs, determines airway volumes and measures regional lung ventilation during
spontaneous breathing. Specific measurements of lobar volume at end inspiration, expiration
and the tidal breathing changes, inspiratory and expiratory lobar flow and estimation of
airway flow resistance using x-ray velocimetry. These variables will be used to explore
indices related to collateral ventilation by comparing time-volume changes based on
segmentation and differential residual. The performance of XV has been assessed in cohort and
case series of patients undergoing therapy for cancer, demonstrating changes in ventilation
distribution and heterogeneity. 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.
Scope: Examine ventilation distribution and heterogeneity using XV functional lung imaging
analysis in moderate to severe COPD undergoing evaluation for BLVR.
Aims: 1) Assess the applicability of XV ventilation distribution and heterogeneity for BLVR
candidate screening compared to conventional tools of quantitative HRCT and ventilation
perfusion scanning.
2) Identify characteristics of lobar ventilation distribution and ventilation heterogeneity
in candidates being assessed for BLVR.
3) Determine whether if there is an association between functional lung imaging data and
clinical status (6MWD, St George's Questionnaire, CAT, mMRC (Modified Medical Research
Council) Dyspnea Scale).
Study Design:
a. Participant Recruitment This is an adaptive trial design in 10 patients in consecutive
recruitment at Temple University Hospital. As subsequent sites initiate investigation, a
small number of roll-in study participants (n=2) will be enrolled for site validation.
Patient managed by Temple University Hospital with inclusion criteria will be identified by
Dr. Gerard Criner for possible inclusion in this study. A waiver for informed consent will be
obtained to allow review of their medical records to determine if these patients may be
eligible for study inclusion. It is anticipated that most of these patients will have known
underlying lung disease. The patient will be screened by the principal investigator or
designee for eligibility. Upon meeting all eligibility criteria, the patient will be
approached by the principal investigator or designee to obtain informed consent for inclusion
into the study. Discussion of the study will take place in a private room and will include
the relevance of this study, risks they may encounter, data collected, and the protection of
their personal information.
All those included in the study will have a diagnosis consistent with existing or potential
clinical work up for BLVR procedure. As this is a cross-sectional study subjects will not be
randomized. The study timeframe for participation will be defined as the time beginning from
recruitment for participation in functional lung imaging which is adjunct measurement to an
existing clinical procedure, until the collection of all data associated with the study. Data
may be collected from medical records whilst the study is approved by the IRB. The clinical
course will neither depend upon, be altered by nor rely on any of the research data collected
as part of this study. To examine the relationship of study data with standard of care,
clinical status, disease exacerbation, prior history of hospitalization, the data collection
period will include historical health records and lung health records before and after the
functional lung imaging scan
