Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000889651p
Ethics application status
Submitted, not yet approved
Date submitted
1/08/2023
Date registered
21/08/2023
Date last updated
21/08/2023
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Regional Lung Ventilation using X-Ray Velocimetry (XV) in Adult Patients with Chronic Respiratory Conditions.
Scientific title
Feasibility of Regional Lung Ventilation using X-Ray Velocimetry (XV) in Adult Patients with Chronic Respiratory Conditions.
Secondary ID [1] 310200 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 330867 0
Asthma 330872 0
Cystic Fibrosis (CF) 330873 0
Idiopathic Pulmonary Fibrosis (IPF) 330874 0
Primary ciliary dyskinesia (PCD) 330875 0
Condition category
Condition code
Respiratory 327665 327665 0 0
Chronic obstructive pulmonary disease
Respiratory 327666 327666 0 0
Asthma
Respiratory 327667 327667 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 327851 327851 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326592 0
Diagnosis / Prognosis
Intervention code [2] 326593 0
Early detection / Screening
Comparator / control treatment
Standard pulmonary function measures (spirometry, multiple breath washout (MBW), diffusing capacity for carbon monoxide (DLCO) and lung volumes.
Spirometry: Measures the volume of air that can be breathed in and out of the lungs. Test involves wearing a nose peg to block air flow from the nose while breathing through the mouth, into a mouthpiece. Participants breathe normally through the mouthpiece, then take a big breath in to fill the lungs, and then blast it out hard and fast to empty the lungs . A maximum of eight blows can be performed to get three acceptable results which takes about 10 minutes.
Multiple breath washout (MBW) measures the efficiency of gas mixing in the lungs and can detect peripheral (smaller) airway function. This test involves wearing a nose peg and normal breathing into a mouthpiece. We may do up to four trials with a rest in between. Test time is variable depending on participant, between 40-60minutes
Lung volumes and DLCO assess how the lungs are expanding and contracting and measure the exchange of oxygen and carbon dioxide between the blood and the air within the lungs. We will not perform these tests for the purpose of the study, but if participants have had these tests done in the last 12 months as part of standard care, we will record these results for the study.
Control group
Active

Outcomes
Primary outcome [1] 335467 0
To assess the feasibility of the XV scanner for the assessment of lung function in patients with chronic respiratory conditions.
Feasibility will be determined comparing XV scan outputs to pulmonary function test measures (spirometric values, MBW, DLCO and lung volumes).
Timepoint [1] 335467 0
Primary evaluation will be done at Visit 1A (main study visit).

Secondary outcome [1] 424762 0
To determine if XV scans provide reproducible values in the assessment of lung function in patients with chronic respiratory conditions, by relative change in XV scan outputs from baseline to repeat scans in 7 to 14 days (Reproducibility Subgroup visit 2)
Timepoint [1] 424762 0
Primary evaluation will be done at Visit 2 (on an optional basis), within 7- 14 days post initial visit 1A (main study visit)
Secondary outcome [2] 425253 0
To determine if XV scans detect responses to bronchodilator in patients with respiratory conditions, compared to spirometry by relative change in XV scan outputs in response to bronchodilator administration (Bronchodilator Subgroup- Visit 1B)
Timepoint [2] 425253 0
Primary evaluation will be done at Visit 1 B (on an optional basis), done on the same day/directly after visit 1A (main study)
Secondary outcome [3] 425581 0
To assess the safety of an XV scanner in adult patients, any adverse events will be reported as both number and frequency and details of each event described. Potential adverse events may include shortness of breath, dizziness or cough, any incidence of these will be reported by the participant. Radiation dosimetry values (Dose Area Product) will summarised using descriptive statistics.
Timepoint [3] 425581 0
Adverse events will be reported on the same day or directly after visit 1A (main study)

Eligibility
Key inclusion criteria
1. 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.
2. Male or female adults, 18 years of age and older.
3. 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently receiving mechanical ventilation, intensive or other critical care.
2. Pregnant women, confirmed by a positive pregnancy test.
3. Women of child-bearing potential who are unable or unwilling to undergo urine pregnancy test(s) to exclude pregnancy at study visit(s).
4. Contraindication to ionising radiation.
5. Patient weight >150kg (limited by XV scanner’s tolerance).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility Analysis: Clinical correlation will be assessed using correlation analysis between XV scan outputs and pulmonary function test measures (spirometric values, MBW, DLCO and lung volumes) using linear regression and reported as correlation coefficients and p-values. Also, the relative change in XV scan outputs will be compared to bronchodilator response as measured by spirometry (minimal response: FEV1 <12% or <200mL, significant response: FEV1 >12% and >200mL). Reproducibility will be assessed by the relative change in XV scan outputs between scan visits for the Reproducibility Sub-group using paired t-tests. Statistical test results will be reported with corresponding 95% CI and p-values.
Safety Analysis: Any adverse events will be reported as both number and frequency, and details of each event described. Radiation dosimetry values (Dose Area Product) will summarised using descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2023
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
13/09/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25292 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 25293 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 25294 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 25295 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 40968 0
2010 - Sydney
Recruitment postcode(s) [2] 40965 0
2031 - Randwick
Recruitment postcode(s) [3] 40966 0
2050 - Camperdown
Recruitment postcode(s) [4] 40967 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 314368 0
Commercial sector/Industry
Name [1] 314368 0
Australian Lung Health Initiative (ALHI)
Country [1] 314368 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St
Kensington
NSW 2052
Country
Australia
Secondary sponsor category [1] 316421 0
None
Name [1] 316421 0
Address [1] 316421 0
Country [1] 316421 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313461 0
Bellberry Limited
Ethics committee address [1] 313461 0
123 Glen Osmond Rd,
Eastwood
SA 5063
Ethics committee country [1] 313461 0
Australia
Date submitted for ethics approval [1] 313461 0
14/08/2023
Approval date [1] 313461 0
Ethics approval number [1] 313461 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128242 0
Prof Adam Jafe
Address 128242 0
Level 8 Centre for Child Health Research & Innovation (ChERI)
The Bright Alliance Building
Cnr of Avoca & High Streets
Randwick 2031
NSW
Country 128242 0
Australia
Phone 128242 0
+61 2 9382 5500
Fax 128242 0
Email 128242 0
adam.jaffe@unsw.edu.au
Contact person for public queries
Name 128243 0
Prof Adam Jafe
Address 128243 0
Level 8 Centre for Child Health Research & Innovation (ChERI)
The Bright Alliance Building
Cnr of Avoca & High Streets
Randwick 2031
NSW
Country 128243 0
Australia
Phone 128243 0
+61 2 9382 5500
Fax 128243 0
Email 128243 0
adam.jaffe@unsw.edu.au
Contact person for scientific queries
Name 128244 0
Dr Nina Eikelis
Address 128244 0
Level 7 Melbourne Connect
700 Swanston Street
Melbourne, Victoria, 3053
Australia
Country 128244 0
Australia
Phone 128244 0
+61 3 9545 5940
Fax 128244 0
Email 128244 0
neikelis@4dmedical.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants and their individual data is confidential and de-identified.
The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorised third party, without prior written approval of UNSW. Clinical information will not be released without written permission of the participant, except as necessary for monitoring by the HREC or regulatory agencies.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.