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MRI for investigating airway clearance techniques in adults with cystic fibrosis

The use of novel magnetic resonance imaging techniques to investigate lung structure and ventilation pre- and post-airway clearance techniques in adults with cystic fibrosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001159943
Enrollment
8
Registered
2020-11-04
Start date
2020-06-30
Completion date
2020-12-18
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to investigate new techniques in magnetic resonance imaging (MRI) pre and post airway clearance techniques (ACT). Adults with CF will be invited to participate, and to perform their usual ACT (i.e. breathing exercises to clear mucus from their airways) within the MRI under the guidance of an experienced physiotherapist. This will allow for innovative cutting edge imaging to be performed before and after the ACT are performed, to provide information on airway structure and function; specifically in regard to the movement of mucous (sputum) and trapped air, and well as dynamic function of the larger airways. This is important, as ACT are one of the cornerstone daily treatments undertaken in CF, yet to date no modern ACT has been shown to be superior, largely due to limited outcome measures. While lung imaging is appealing, until recently only computed tomography (CT) has been available to provide the necessary imaging. Unfortunately, CT exposes the patient to ionising radiation exposure which limits its use for especially functional imaging. Using MRI provides avoids radiation risk, therefore is an excellent option for structure and function imaging in relation to ACT. This is the first study of its kind, utilising novel MRI techniques. The experienced and capable research team will investigate the use of novel MRI techniques to objectively quantify lung structure and ventilation during ACT in adults with CF, providing new data in this area to assist in the understanding of ACT in the future. The MRI techniques used have the potential to also be used in other lung diseases such as bronchiectasis, COPD and asthma, and therefore this study is the beginning of a much larger research focus in this field. Aims In adults with CF: 1) Establish a protocol for the use of MRI to detect changes in lung structure and ventilation in relation to mucus movement during ACT; 2) Conduct a series of three MRI in adults with CF (n = 12) of varying disease severities before and after different ACT to explore the obtainable information including mucus movement and static and dynamic airway ventilation. Hypothesis MRI is a novel and suitable tool for the assessment of lung structure and ventilation during ACT in adults with CF, which will provide a new outcome measure for use in future larger clinical trials in this area. Each participant will complete three separate MRI scans, lasting approximately 20 minutes each, interspersed throughout the visit. They will also complete a 25 minute control period of resting breathing, and a 25 minute intervention period consisting of performing their usual ACT. The order of the intervention and control periods will be determined by randomisation. The ACT performed at each visit will be supervised by Jamie Wood and ACT will be performed according to International Physiotherapy Group for CF guidelines.

Interventions

This is a single visit, proof of concept study investigating the use of a novel outcome measure (magnetic resonance imaging [MRI]) to measure changes in lung structure and ventilation following airway clearance techniques in adults with CF. Each participant will complete three MRI scans (each lasting approximately 20 minutes): firstly at the commencement of the visit, then after airway clearance techniques or washout period (25 minutes) and then again after airway clearance techniques or washout

This is a single visit, proof of concept study investigating the use of a novel outcome measure (magnetic resonance imaging [MRI]) to measure changes in lung structure and ventilation following airway clearance techniques in adults with CF. Each participant will complete three MRI scans (each lasting approximately 20 minutes): firstly at the commencement of the visit, then after airway clearance techniques or washout period (25 minutes) and then again after airway clearance techniques or washout period (25 minutes), conducted in randomised order (i.e. one period of airway clearance and one washout period per participant in a randomised order). The total study visit is expected to last no more than 2 hours. The participant will complete their usual airway clearance technique, supervised by an experienced CF physiotherapist. The MRI scans will be completed by an experienced MRI technician.

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of CF; aged 18 years or older; under the care of the SCGH CF team; no signs of a respiratory exacerbation in the preceding four weeks.

Exclusion criteria

Previous lung transplantation; inability to perform ACT; inability to expectorate mucus; type 1 respiratory failure requiring supplemental oxygen therapy; pneumothorax in the previous 3 months; current haemoptysis; pregnancy; failing to comply with standardised pre-MRI safety checklists; potential intolerance to MRI environment due to severe claustrophobia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026