Upright MRI in Lung Disease
Primary Purpose
COPD With Hyperinflation, Diaphragmatic Weakness
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Upright MRI
Sponsored by
About this trial
This is an interventional other trial for COPD With Hyperinflation focused on measuring upright MRI, COPD with hyperinflation, Diaphragmatic weakness
Eligibility Criteria
Inclusion Criteria:
General inclusion criteria:
- Adult - Male or female, aged 18 to 90 years old
- Capacity to give informed consent
- Able to hold their breath for 10 seconds
- Able to understand the requirements of the study and to cooperate with the study procedures
- Cohort-specific inclusion criteria:
Healthy participants
- No reported or diagnosed chronic respiratory disease
COPD with hyperinflation
- Evidence of airflow obstruction on spirometry - FEV1/FVC < 0.7 and FEV1 <80%. (FEV1 = full expiratory volume in 1 second, FVC = full vital capacity)
- Diagnosis of hyperinflation based on imaging or lung function measures.
Diaphragm weakness due to non-neuromuscular disease
- Established diagnosis of diaphragm weakness due to non-neuromuscular disease, e.g. viral illness, trauma.
Diaphragm weakness due to neuromuscular disease
- Established diagnosis of diaphragm weakness due to neuromuscular disease
Exclusion Criteria:
- Unsuitable for MRI scanning (e.g. have metal implants/pacemaker or contraindicated following questionnaire)
- Deemed unlikely to comply with instructions during imaging
- Deemed not fit enough to tolerate procedure
- Deemed unsuitable by clinical investigator for other reasons
- History of lung volume reduction procedure
Sites / Locations
- Nottingham University Hospitals NHS TrustRecruiting
- University of NottinghamRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Upright MRI
Arm Description
All participants will be scanned using an upright MRI in seated/standing position and supine position. They will also be scanned supine using a conventional MRI.
Outcomes
Primary Outcome Measures
The diaphragm will be imaged using MRI in horizontal and vertical positions.
Images will be anonymised and stored securely on University servers.
The change in diaphragm position and morphology on MRI following a change in posture (vertical to horizontal position or vice versa) will be measured.
The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI.
The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI.
Secondary Outcome Measures
The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI.
The patients' symptoms, as reported on St George's Respiratory Questionnaire and a visual analogue scale for breathlessness, will be compared to the abnormalities noted in diaphragm position and morphology on MRI.
Participants will be asked to fill St George's Respiratory questionnaire and a visual analogue scale for breathlessness to assess symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03531775
Brief Title
Upright MRI in Lung Disease
Official Title
Upright Magnetic Resonance Imaging in COPD and Diaphragm Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2018 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The diaphragm is the main muscle assisting breathing. This study aims to assess the use of MRI in patients with diaphragmatic weakness and patients with Chronic Obstructive Pulmonary Disease (COPD) who have hyperinflation. In some patients with COPD, air gets trapped in the lungs and causes them to expand too much; this is called hyperinflation. These patient report severe breathlessness, which may be in part because of their diaphragm. It is known that posture impacts lung function and breathing and the investigators want to assess the effect of posture on the diaphragm. Currently, lung function tests and CT or ultrasound scan are the main tests used to check how the diaphragm works. Recently, at University of Nottingham, an new imaging approach has been developed that uses an upright MRI allowing testing the patients in lying position and seated/standing in the same scanner. This may help researchers test the diaphragm position and shape more accurately and check the effects of posture on the diaphragm. This may help researchers and clinicians better understand the relationship between postural changes in diaphragm position and shape and symptoms.
The study will take place at the clinical research MRI centre at Nottingham Medical School, which is next to Queen's Medical Centre. The investigators want to recruit healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are hyperinflated. The study will last 2 years, and the participants are asked to attend the imaging centre only once, where they will give consent and will be scanned at the same visit, which is expected to take 2 hours to complete. They will be scanned on two scanners: lying and seated/standing in the new upright scanner and lying in a conventional scanner. The investigators will not use any contrast for imaging, i.e. participants will not be injected with a dye and they will breathe air.
Detailed Description
This is a single centre, proof of concept clinical trial. The investigators want to recruit healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are hyperinflated. Half the investigators are clinicians and have asked their patient whether such a study would interest them, and patients have been very supportive. This study addresses an unanswered clinical question.
The participants will be adults, men and women, who can give informed consent, and can cooperate with the study procedures. As the participants will be scanned using MRI, people who are unsuitable for MRI scanning, for example those with a pacemaker, will be excluded from the study for safety reasons.The participant will be observed by a clinical investigator throughout the study visit.
As for side effects / risks, no medicinal products will be administered in this study. Some participants may experience anxiety while undergoing MRI scan. It is expected that some patients may not be able to lie flat in the scanner, in which case they will be asked only to undergo scans that they are able to tolerate.
In addition to being scanned using an upright MRI and a conventional MRI, the following measurements will be takes: weight, height, blood pressure, heart rate, oxygen saturation, respiratory rate, and spirometry. The participants will be asked to fill a St George's Respiratory Questionnaire and an MRC (Medical Research Council) Dyspnoea Scale. A detailed medical history will be taken.
The participants will be assigned unique codes, and their data will be anonymised. Participants' medical reports will only be accessed for study purposes and will be treated as confidential.
The investigators will aim to use the data to plan future studies, and the data from this study may contribute to publications and presentations. Participants will not be identified in any publications arising from the research. The data obtained will be published without any identifying information..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD With Hyperinflation, Diaphragmatic Weakness
Keywords
upright MRI, COPD with hyperinflation, Diaphragmatic weakness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trial to study a novel intervention (upright MRI) to compare interventions in clinical practice
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Upright MRI
Arm Type
Other
Arm Description
All participants will be scanned using an upright MRI in seated/standing position and supine position. They will also be scanned supine using a conventional MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Upright MRI
Intervention Description
Participants will be scanned using an upright MRI in sitting/standing position and supine position. They will also be scanned in supine position using a conventional MRI.
Primary Outcome Measure Information:
Title
The diaphragm will be imaged using MRI in horizontal and vertical positions.
Description
Images will be anonymised and stored securely on University servers.
Time Frame
2 years
Title
The change in diaphragm position and morphology on MRI following a change in posture (vertical to horizontal position or vice versa) will be measured.
Time Frame
2 years
Title
The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI.
Time Frame
2 years
Title
The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI.
Time Frame
2 years
Title
The patients' symptoms, as reported on St George's Respiratory Questionnaire and a visual analogue scale for breathlessness, will be compared to the abnormalities noted in diaphragm position and morphology on MRI.
Description
Participants will be asked to fill St George's Respiratory questionnaire and a visual analogue scale for breathlessness to assess symptoms.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
General inclusion criteria:
Adult - Male or female, aged 18 to 90 years old
Capacity to give informed consent
Able to hold their breath for 10 seconds
Able to understand the requirements of the study and to cooperate with the study procedures
Cohort-specific inclusion criteria:
Healthy participants
No reported or diagnosed chronic respiratory disease
COPD with hyperinflation
Evidence of airflow obstruction on spirometry - FEV1/FVC < 0.7 and FEV1 <80%. (FEV1 = full expiratory volume in 1 second, FVC = full vital capacity)
Diagnosis of hyperinflation based on imaging or lung function measures.
Diaphragm weakness due to non-neuromuscular disease
Established diagnosis of diaphragm weakness due to non-neuromuscular disease, e.g. viral illness, trauma.
Diaphragm weakness due to neuromuscular disease
Established diagnosis of diaphragm weakness due to neuromuscular disease
Exclusion Criteria:
Unsuitable for MRI scanning (e.g. have metal implants/pacemaker or contraindicated following questionnaire)
Deemed unlikely to comply with instructions during imaging
Deemed not fit enough to tolerate procedure
Deemed unsuitable by clinical investigator for other reasons
History of lung volume reduction procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahideh Safavi
Phone
00441158231154
Email
shahideh.safavi@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahideh Safavi
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahideh Safavi
Phone
00441158231154
Email
shahideh.safavi@nottingham.ac.uk
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahideh Safavi
Phone
00441158231154
Email
shahideh.safavi@nottingham.ac.uk
12. IPD Sharing Statement
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Upright MRI in Lung Disease
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