ANZCTR - Registration

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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]

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

chronic lung disease, including Primary ciliary dyskinesia (PCD)

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Human Genetics and Inherited Disorders

Cystic fibrosis

Human Genetics and Inherited Disorders

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]

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]

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]

Assessed at the conclusion of the study

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,SA

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [2]

Sydney Children's Hospital - Randwick

Recruitment postcode(s) [1]

5006 - North Adelaide

Recruitment postcode(s) [2]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Women's and Children's Hospital

Address [1]

72 King William St
Adelaide
SA 5000

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

4DMedical

Address [2]

Level 7 Melbourne Connect
700 Swanston Street
Melbourne, Victoria, 3053
Australia

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

A/Prof Adam Jaffe

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

72 King William Road
North Adelaide
5006 SA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/11/2021

Approval date [1]

22/02/2022

Ethics approval number [1]

2021/HRE00396

Summary

Brief summary

Lung health is mostly measured by “blowing tests”, known as spirometry. These types of tests can give useful information about lung health, but they can’t show exactly where in the lung any disease may be present. Other tests like computed tomography (CT) can give doctors useful and detailed information about the structure of the lungs, but this is different information to measuring how the lung is actually working as you breathe. We are trialing a new test called XV LVAS which will show how well different areas of the lung are working. This test is not currently approved for use in children but might help doctors to treat conditions like cystic fibrosis. We are recruiting children with healthy lungs and children with cystic fibrosis and other chronic lung diseases to decide if this test should be used with other lung tests to help doctors treat lung diseases like cystic fibrosis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Thomas Goddard

Address

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

Australia

Phone

+61401914370

Fax

tom.goddard@sa.gov.au

Contact person for public queries

Name

Jessica Phillips

Address

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

Australia

Phone

+61 8 8161 9179

Fax

jessica.phillips2@sa.gov.au

Contact person for scientific queries

Name

Kristin Carson-Chahhoud

Address

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

Australia

Phone

+61 881619179

Fax

Kristin.Carson@unisa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
23759	Other	Bruorton 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-2023-080034	https://bmjopen.bmj.com/content/14/2/e080034	matthew.bruorton@sa.gov.au	Methods publication

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	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	2024	https://doi.org/10.1136/bmjopen-2023-080034

N.B. These documents automatically identified may not have been verified by the study sponsor.

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