Trial Review

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
ACTRN12618001942246
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
29/11/2018
Date last updated
29/11/2018
Date data sharing statement initially provided
29/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of lung function using MRI scans in people with moderate chronic lung disease
Scientific title
A comparative study: measuring ventilation (V) and perfusion (Q) in healthy volunteers and patients with moderate chronic respiratory disease
Secondary ID [1] 296633 0
none
Universal Trial Number (UTN)
U1111-1216-9587
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 310468 0
pulmonary fibrosis 310469 0
Condition category
Condition code
Respiratory 309181 309181 0 0
Other respiratory disorders / diseases
Respiratory 309182 309182 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
magnetic resonance imaging (MRI)
The test will be administered a trained medical physicist and radiology technologist at the Centre for Cardiac Magnetic Resonance Imaging at the University of Auckland. Each participant will have one MRI and the torso will be imaged. There is no radiation dose. The procedure takes approximately 30 minutes. Eight healthy volunteers have already been recruited and the data from those participants helped set the algorithms for the study of 8 participants with diseased lungs
Intervention code [1] 312951 0
Early detection / Screening
Comparator / control treatment
The eight healthy volunteers were used to set the imaging parameters in this pilot study. There will be no direct comparison of physiologic or imaging data and hence they are not true controls. That part of the study has been completed
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308157 0
MRI measured regional ventilation/perfusion ratio (V/Q)
Timepoint [1] 308157 0
at time of measurement
Secondary outcome [1] 354102 0
tolerance of procedure will be measured by whether the patient can lie flat for the duration of the test. Tests that are aborted because of patient discomfort will be noted. There is no validated tool that allows us to describe this better. We will ask patients if they would consider that MRI is a test that they would consider having as part of routine diagnosis based on their experience on the day. This is a pilot study.
Timepoint [1] 354102 0
at measurement

Eligibility
Key inclusion criteria

Adult patients with moderate severity COPD or idiopathic pulmonary fibrosis
COPD: FEV1 <70% >50% predicted
IPF: FVC < 90 >50% predicted and/or DLCO <80 >50% predicted
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
inability to lie flat for MRI scan

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Efficacy
Statistical methods / analysis
pilot study to assess methodology and descriptive statistics only

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/12/2018
Actual
Date of last participant enrolment
Anticipated
29/03/2019
Actual
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 21049 0
New Zealand
State/province [1] 21049 0

Funding & Sponsors
Funding source category [1] 301212 0
Charities/Societies/Foundations
Name [1] 301212 0
Green Lane Research and Education Fund
Country [1] 301212 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Research Office
Auckland District Health Board
Private Bag 92024
Wellesley St
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 300844 0
None
Name [1] 300844 0
Address [1] 300844 0
Country [1] 300844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301958 0
Ministry of Health, Health and Disability Ethics Committee
Ethics committee address [1] 301958 0
Ministry of Health
133 Molesworth St
PO Box 5018
Wellington 6011
Ethics committee country [1] 301958 0
New Zealand
Date submitted for ethics approval [1] 301958 0
13/08/2018
Approval date [1] 301958 0
17/10/2018
Ethics approval number [1] 301958 0
18-NTA-139

Summary
Brief summary
The aim of the study is to develop functional MRI capabilities at the Centre for Advanced MRI (CAMRI) to measure regional lung function. This is a proof of concept study - to develop, test and establish functional MRI techniques – providing a non-invasive, non-ionising imaging method to measure regional ventilation, perfusion and tissue density in the lung. Initial protocol development has been undertaken in approximately 8 healthy volunteers. This will now be followed by a comparative study of measurements of ventilation (V) and perfusion (Q) in approximately 8 patients with various respiratory disease (with known V/Q dysfunction) against data from 8 healthy age matched volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88670 0
Prof Margaret Wilsher
Address 88670 0
Auckland District Health Board
Private Bag 92024
Wellesley St
Auckland 1142
Country 88670 0
New Zealand
Phone 88670 0
+64 21 326326
Fax 88670 0
Email 88670 0
[email protected]
Contact person for public queries
Name 88671 0
Prof Margaret Wilsher
Address 88671 0
Auckland District Health Board
Private Bag 92024
Wellesley St
Auckland 1142
Country 88671 0
New Zealand
Phone 88671 0
+64 21 326326
Fax 88671 0
Email 88671 0
[email protected]
Contact person for scientific queries
Name 88672 0
Prof Margaret Wilsher
Address 88672 0
Auckland District Health Board
Private Bag 92024
Wellesley St
Auckland 1142
Country 88672 0
New Zealand
Phone 88672 0
+64 21 326326
Fax 88672 0
Email 88672 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 only a pilot study


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
317Study protocol    376403-(Uploaded-19-11-2018-11-16-25)-Study-related document.docx
318Ethical approval    376403-(Uploaded-19-11-2018-11-16-46)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
317Study protocol    376403-(Uploaded-19-11-2018-11-16-25)-Study-related document.docx
318Ethical approval    376403-(Uploaded-19-11-2018-11-16-46)-Study-related document.pdf
23705Informed consent form   
23706Informed consent form   
23707Informed consent form    376403-(Uploaded-09-01-2020-10-04-04)-Study-related document.docx

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3857Basic resultsNo 376403-(Uploaded-31-10-2019-13-29-29)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.