RecruitingACTRN12623000889651

Feasibility of Regional Lung Ventilation using X-Ray Velocimetry (XV) in Adult Patients with Chronic Respiratory Conditions.

Sponsor

University of New South Wales

Enrollment

60 participants

Start Date

Oct 18, 2024

Study Type

Interventional

Conditions

Primary ciliary dyskinesia (PCD)Asthma Chronic Obstructive Pulmonary Disease (COPD)Idiopathic Pulmonary Fibrosis (IPF)Cystic Fibrosis (CF)

Summary

Most chronic lung conditions cause variable changes in the movement of air within the lungs (known as regional lung ventilation), and therefore alter how the lungs function. These changes are difficult to detect early by conventional lung function tests, such as spirometry. The newly developed 'XVD lung scanner' intends to provide a quick, non-invasive and accurate assessment of regional lung ventilation, which may allow for earlier diagnosis and improved monitoring of patients with chronic lung conditions. This scanner is a medical imaging device which captures four images of the lungs during one breath, in the seated position. These are combined with recent lung CT scan images and using XV software, produce an XV scan report. We aim to scan the lungs of 60 adults with chronic respiratory conditions assess feasibility compared to other pulmonary function test measures used in standard clinical practice.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Has a known history of a chronic respiratory condition (such as COPD, asthma, CF, IPF or PCD) that is clinically stable, as defined by no change in medications or hospitalisations, over the preceding four-week period, prior to study recruitment.
Male or female adults, 18 years of age and older.
Is known to require a chest CT or has a historical chest CT that is representative of the patient’s present lung anatomy (i.e. ideally undertaken within 12-24 months of recruitment to the study).

Exclusion Criteria5

Currently receiving mechanical ventilation, intensive or other critical care.
Pregnant women, confirmed by a positive pregnancy test.
Women of child-bearing potential who are unable or unwilling to undergo urine pregnancy test(s) to exclude pregnancy at study visit(s).
Contraindication to ionising radiation.
Patient weight >150kg (limited by XV scanner’s tolerance).

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Interventions

We are assessing the utility of a medical imaging device XV (short for X-ray Velocimetry Technology) which refers to emerging platform technologies for quantifying and visualising regional lung ventilation to provide functional lung imaging in the surveillance of lung function. XV is a collective term in reference to (1) XV Scanner, a purpose-built medical imaging scanner that acquires fluoroscopic images of a person’s lungs, and (2) XV Software, a cloud-based post-processing software program that utilises fluoroscopic lung images (in combination with separately acquired CT chest images) to generate a quantitative regional lung ventilation report (XV Report) for clinical researchers (Investigators). The XV scanner consists of a multi-source X-ray machine that captures four synchronised, cinefluorographic images of the participant’s lungs during one breath cycle, while the participant is seated. The XV scan time is less than one minute, and the overall scan time is approximately 10 minutes to account for scanning set-up, correct positioning and engagement with the participant. The scan will be performed by a suitably trained and qualified radiographer. These images are combined with recent CT chest scan images of the participant, and uploaded to the XV scanners cloud software to generate a final XV scan report. To assess the utility of an XV scanner in the surveillance of lung function, the correlation of XV scan outputs versus standard pulmonary function measures (spirometry and multiple breath washout (MBW) will be determined. These tests will be performed prior to the XV scan and depending of participant will take between 40-60 minutes. There are 2 optional sub studies: One is to assess the effect of a bronchodilator in those participants who have undertaken the main study and that are eligible (have a diagnosis of asthma or COPD). This will be performed on the same day as the main study, directly after completion of the initial XV scanner (described above). A bronchodilator (provided by study team) is given to participants (up to four puffs of salbutamol). Fifteen minutes after medication is administered, repeat spirometry and MBW breathing tests and another XV lung scan is taken (as described above in the Main Study). The second sub-study is a repeatability study available to all study participants who completed the main study. This will be a repeat of the main study (as above) where the XV scan and lung function testing is repeated within 7 to 14 days of the initial scan.