RecruitingACTRN12623000109606

Regional lung ventilation in children via X-ray Velocimetry (XV)

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


Sponsor

Women's and Children's Hospital, Department of Respiratory and Sleep Medicine

Enrollment

60 participants

Start Date

Nov 3, 2022

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Standard lung function tests like spirometry (blowing into a tube) can tell us a lot about overall lung health, but they can't show exactly which parts of the lung are affected. A new imaging technology called X-ray Velocimetry (XV) uses low-dose X-rays to create a real-time map of how different regions of the lung are ventilating — essentially showing the lung in action, region by region. This study is testing whether XV is safe and useful in children, focusing on those with cystic fibrosis and other chronic lung diseases compared to healthy controls. If proven valuable, this test could help doctors identify localised lung damage earlier and tailor treatments more precisely for children with these conditions. You may be eligible if your child is aged 3 to 18, has had or is scheduled for a clinical CT scan within the last 3 months, and belongs to one of three groups: healthy controls, cystic fibrosis patients, or children with other chronic lung conditions. Children currently on mechanical ventilation, receiving urgent treatment, or unable to remain still for 30 seconds are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(2)

Womens and Childrens Hospital - North Adelaide

NSW,SA, Australia

Sydney Children's Hospital - Randwick

NSW,SA, Australia

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ACTRN12623000109606


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