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Upright MRI in Lung Disease

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ClinicalTrials.gov Identifier: NCT03531775
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Shahideh Safavi, University of Nottingham

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.


Condition or disease Intervention/treatment Phase
COPD With Hyperinflation Diaphragmatic Weakness Diagnostic Test: Upright MRI Not Applicable

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..


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical trial to study a novel intervention (upright MRI) to compare interventions in clinical practice
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Upright Magnetic Resonance Imaging in COPD and Diaphragm Disease
Estimated Study Start Date : July 16, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Upright MRI
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.
Diagnostic Test: Upright MRI
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 Measures :
  1. The diaphragm will be imaged using MRI in horizontal and vertical positions. [ Time Frame: 2 years ]
    Images will be anonymised and stored securely on University servers.

  2. 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 ]
  3. The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI. [ Time Frame: 2 years ]
  4. The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI. [ Time Frame: 2 years ]
  2. 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. [ Time Frame: 2 years ]
    Participants will be asked to fill St George's Respiratory questionnaire and a visual analogue scale for breathlessness to assess symptoms.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531775


Contacts
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Contact: Shahideh Safavi 00441158231154 shahideh.safavi@nottingham.ac.uk

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Shahideh Safavi    00441158231154    shahideh.safavi@nottingham.ac.uk   
University of Nottingham Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Shahideh Safavi    00441158231154    shahideh.safavi@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Shahideh Safavi University of Nottingham

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Responsible Party: Shahideh Safavi, Principal Investigator, University of Nottingham
ClinicalTrials.gov Identifier: NCT03531775     History of Changes
Other Study ID Numbers: 18011
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shahideh Safavi, University of Nottingham:
upright MRI
COPD with hyperinflation
Diaphragmatic weakness