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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620001159943

Ethics application status

Approved

Date submitted

29/06/2020

Date registered

4/11/2020

Date last updated

4/11/2020

Date data sharing statement initially provided

4/11/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

MRI for investigating airway clearance techniques in adults with cystic fibrosis

Scientific title

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cystic fibrosis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Human Genetics and Inherited Disorders

Cystic fibrosis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The participant is being used as their own comparator/control during the washout period in the study design. During this period, the participant will sit in a quiet room and be instructed to breathe normally/rest.

Control group

Active

Outcomes

Primary outcome [1]

1) Lung structure We will use a version of the PRAGMA-CF scoring system (widely used in CF CT scan studies), adapted for use in MRI, for assessment of structural lung abnormalities.15 In brief, PRAGMA-CF involves overlaying a square grid over the MRI images and annotating grid cells for the presence of CF-related structural lung disease. The total proportion of the lung with disease, %Disease, is reported and represents the extent of structural disease. Additionally, the extent of mucus plugging, %MucusPlugging, will be reported.

Timepoint [1]

On day of MRI

Primary outcome [2]

2) Lung ventilation The same PRAGMA-CF process will be used to determine the severity of hypoventilation in the lung, from the Fourier Decomposition scans (%Hypoventilated).

Timepoint [2]

On day of MRI

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled 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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

All scans will be retrieved and de-identified before analysis. Assessment of MRI scans will be performed in random order, blinded to clinical and research outcomes. The PRAGMA-CF scoring system, adapted for use in MRI, for assessment of structural lung abnormalities. This involves overlaying a square grid over the MRI images and annotating grid cells for the presence of CF-related structural lung disease. This will be performed by a scientist blinded to group allocation, who is experienced in using this scoring system.

The total proportion of the lung with disease, %Disease, is reported and represents the extent of structural disease. Additionally, the extent of mucus plugging, %MucusPlugging, will be reported. The same process will be used to determine the severity of hypoventilation in the lung, from the Fourier Decomposition scans (%Hypoventilated).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

30/06/2020

Date of last participant enrolment

Anticipated

18/12/2020

Actual

Date of last data collection

Anticipated

18/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue, Nedlands, Western Australia 6009

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Avenue, Nedlands, Western Australia 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee

Ethics committee address [1]

Hospital Avenue, Nedlands, Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/10/2019

Approval date [1]

31/05/2020

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Jamie Wood

Address

Sir Charles Gairdner Hospital Physiotherapy Department Ground Floor A Block Hospital Avenue Nedlands WA 6009

Country

Australia

Phone

+61 432 954 790

Fax

[email protected]

Contact person for public queries

Name

Jamie Wood

Address

Sir Charles Gairdner Hospital Physiotherapy Department Ground Floor A Block Hospital Avenue Nedlands WA 6009

Country

Australia

Phone

+61 432 954 790

Fax

[email protected]

Contact person for scientific queries

Name

Jamie Wood

Address

Sir Charles Gairdner Hospital Physiotherapy Department Ground Floor A Block Hospital Avenue Nedlands WA 6009

Country

Australia

Phone

+61 432 954 790

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Available to those who request the information via contacting the principal investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?

• The raw line data regarding the PRAGMA MRI scoring will be made available on request.

What types of analyses could be done with individual participant data?

• Only to achieve the aims in the approved proposal and case-by-case at discretion of the Principal Investigator.

When can requests for individual participant data be made (start and end dates)?

From:
Unknown start date at present

To:
following publication of the manuscript and until the proposed end of the HREC approval (31/12/2021)

Where can requests to access individual participant data be made, or data be obtained directly?

• Via the principal investigator ([email protected]) and following HREC approval at the site the research is being undertaken.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically