Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000109606
Ethics application status
Approved
Date submitted
23/01/2023
Date registered
1/02/2023
Date last updated
4/10/2024
Date data sharing statement initially provided
1/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regional lung ventilation in children via X-ray Velocimetry (XV)
Scientific title
Feasibility study of paediatric regional lung function assessment via X-ray Velocimetry (XV) imaging in children with healthy lungs or cystic fibrosis and other chronic lung diseases
Secondary ID [1] 308811 0
Nil known
Universal Trial Number (UTN)
U1111-1287-9096
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 328770 0
chronic lung disease, including Primary ciliary dyskinesia (PCD) 335380 0
Condition category
Condition code
Respiratory 325778 325778 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 325810 325810 0 0
Cystic fibrosis
Human Genetics and Inherited Disorders 331956 331956 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are investigating the feasibility of undertaking regional lung function imaging of children with healthy lungs, and children with CF or other chronic lung diseases, as revealed by X-ray Velocimetry (XV). This XV LVAS technology which has not been utilised in a paediatric cystic fibrosis population previously. This will be compared to CT and lung function testing which is the current gold standard of care for CF patients. This will be a single time point comparison with one set of imaging and lung function per participant.
XV LAS imaging requires a series of 5 x-rays taken from different angles around the chest while the patient is breathing normally and will take about 5 minutes of imaging. X-rays are acquired over the duration of one normal breath at each position. This allows specialist software (XV LAS, 4Dmedical) to examine the CT scan with the x-ray images to show how well each lung segment is working. This provides additional information compared to CT scans, x-rays or lung function testing on their own as it shows a heat map of the lung, identifying how well regions of the lung are functioning. This additional information can help advise doctors on whether treatments such as medications and physiotherapy are working well or need to be modified as well as mapping any structural changes.
Participants will be asked to attend clinic for 30 minutes for consent, a physical exam and medical history, then attend lung function for 1.5-2 hours to complete lung function testing (spirometry, lung volume, diffusing capacity) and radiology for 30 minutes for the XV LVAS x-rays. These activities can be spread across different days or correspond with other hospital appointments if necessary to reduce patient burden.
Intervention code [1] 325264 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator in this study is the lung function of Healthy Control children. As there is no current data set of XV imaging in healthy children's lungs we will evaluate the technology in healthy and cystic-fibrosis affected lungs and compare to standard lung function testing within groups. Standard lung function will include Spirometry, plethysmography, diffusing capacity, multiple breath washout, We will also use chest CT data from standard care, and in addition perform an x-ray for XV LAS analysis which will allow us to image healthy paediatric lungs to compare with cystic fibrosis lungs.
Control group
Active

Outcomes
Primary outcome [1] 333624 0
The primary outcome measure is feasibility to recruit children with healthy lungs and those with CF and chronic lung disease to participate in a future XV imaging study. As XV LAS imaging requires a CT in addition to x-ray, only children receiving a CT scan as part of clinical care will be included due to the radiation risks. The feasibility will be assessed by the number participating children, and eligible but not participating children to allow the study to be scaled up, over a 12-month period.
Timepoint [1] 333624 0
Assessed at the conclusion of the study
Secondary outcome [1] 417782 0
To determine the mean and standard deviation of XV LVAS measurements in healthy and cystic-fibrosis or chronic lung disease affected lungs to determine appropriate sample size to investigate this technology in a larger study. XV LVAS output measures include lobar ventilation distribution, ventilation heterogeneity and expiratory time constant. This will be assessed using XV LVAS data output within the two patient groups. Clinician input will determine the most important measures to be used for power calculations to upscale the study.
Timepoint [1] 417782 0
Assessed at the conclusion of the study

Eligibility
Key inclusion criteria
1. Age 3-18 years, male or female
2. CT scan performed within last 3 months or scheduled for clinical CT scan
3. Belong to one of the following arms:
Arm 1 - Control
Arm 2 - Cystic Fibrosis
Arm 3 - Chronic Lung Disease
Minimum age
3 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently receiving mechanical ventilation, intensive or other critical care
2, Contraindication to ionizing radiation
3. Pre-existing lung disease in Arm 1 - Control patients, e.g. asthma, interstitial lung disease, etc
4. Urgent clinical treatment precluding XV imaging
5. Inability to comply and remain still for periods of 30 seconds for the five XV image acquisitions
6. Unable to perform standard lung function testing

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size of 2o Controls, 20 CF and 20 chronic lung disease patients was chosen for this feasibility to determine the range and standard deviation of XV LVAS derived data to determine sample size for a larger cohort study to follow.
The XV and Lung Function Test outcome data obtained from this study will be described by group (children with healthy lungs and children with CF) using descriptive statistics. Continuous variables will be described using mean and standard deviation, or median and interquartile range (IQR) if the distribution is asymmetric. Categorical variables will be presented as numbers and percentages. Demographic variables age, sex, height and weight will also be described by group. Association between outcome measures will be assessed graphically and described using correlation coefficients

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/11/2022
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
29/12/2024
Actual
Sample size
Target
60
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 23870 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 27192 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 39327 0
5006 - North Adelaide
Recruitment postcode(s) [2] 43275 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 313026 0
Hospital
Name [1] 313026 0
Women's and Children's Hospital
Country [1] 313026 0
Australia
Funding source category [2] 313028 0
Commercial sector/Industry
Name [2] 313028 0
4DMedical
Country [2] 313028 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital, Department of Respiratory and Sleep Medicine
Address
72 King William St
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 314720 0
None
Name [1] 314720 0
Address [1] 314720 0
Country [1] 314720 0
Other collaborator category [1] 283248 0
Other Collaborative groups
Name [1] 283248 0
A/Prof Adam Jaffe
Address [1] 283248 0
Country [1] 283248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312288 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 312288 0
Ethics committee country [1] 312288 0
Australia
Date submitted for ethics approval [1] 312288 0
18/11/2021
Approval date [1] 312288 0
22/02/2022
Ethics approval number [1] 312288 0
2021/HRE00396

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

Contacts
Principal investigator
Name 124118 0
Dr Thomas Goddard
Address 124118 0
Department of Respiratory and Sleep Medicine, Level 6 Gilbert Building, 72 King William Rd., Women's and Children's Hospital, North Adelaide, SA, 5006
Country 124118 0
Australia
Phone 124118 0
+61401914370
Fax 124118 0
Email 124118 0
[email protected]
Contact person for public queries
Name 124119 0
Jessica Phillips
Address 124119 0
Department of Respiratory and Sleep Medicine, Level 6 Gilbert Building, 72 King William Rd., Women's and Children's Hospital, North Adelaide, SA, 5006
Country 124119 0
Australia
Phone 124119 0
+61 8 8161 9179
Fax 124119 0
Email 124119 0
[email protected]
Contact person for scientific queries
Name 124120 0
Kristin Carson-Chahhoud
Address 124120 0
Department of Respiratory and Sleep Medicine, Level 6 Gilbert Building, 72 King William Rd., Women's and Children's Hospital, North Adelaide, SA, 5006
Country 124120 0
Australia
Phone 124120 0
+61 881619179
Fax 124120 0
Email 124120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small feasibility study and so this data set would not be valuable for analysis in isolation.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23759OtherBruorton M, Donnelley M, Goddard T, et al, Pilot study of paediatric regional lung function assessment via X-ray velocimetry (XV) imaging in children with normal lungs and in children with cystic fibrosis. BMJ Open 2024;14:e080034. doi: 10.1136/bmjopen-2023-080034https://bmjopen.bmj.com/content/14/2/e080034[email protected] Methods publication



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPilot study of paediatric regional lung function assessment via X-ray velocimetry (XV) imaging in children with normal lungs and in children with cystic fibrosis2024https://doi.org/10.1136/bmjopen-2023-080034
N.B. These documents automatically identified may not have been verified by the study sponsor.