Upright MRI in Lung Disease

NCT03531775 | Unknown

• 1 other identifier: 18011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD With Hyperinflation; Diaphragmatic Weakness

Keywords

upright MRI; COPD with hyperinflation; Diaphragmatic weakness

Outcome Measures

Primary Outcomes (4)

• The diaphragm will be imaged using MRI in horizontal and vertical positions.

  Images will be anonymised and stored securely on University servers.

  2 years

• The change in diaphragm position and morphology on MRI following a change in posture (vertical to horizontal position or vice versa) will be measured.

  2 years

• The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI.

  2 years

• The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI.

  2 years

Secondary Outcomes (2)

• The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI.

  2 years

• 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.

  2 years

Study Arms (1)

Upright MRI

OTHER

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

Interventions

Upright MRI DIAGNOSTIC_TEST

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.

Upright MRI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

RECRUITING

Study Officials

• Shahideh Safavi

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahideh Safavi

CONTACT

00441158231154; shahideh.safavi@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical trial to study a novel intervention (upright MRI) to compare interventions in clinical practice

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 22, 2018
• Study Start: July 16, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

GB (2)