MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology

NCT04872309 | Suspended

• 1 other identifier: STH20825
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Lung magnetic resonance imaging (MRI) with proton and inhaled inert gases has demonstrated a clinical ability to provide valuable structural and functional information in lung disease. Advances in lung MRI methods have led to the STH department handling clinical imaging referrals from local and national respiratory units. Hyperpolarised Xenon-129 gas MRI is now the gold-standard MRI modality used in clinical practice for asthma and COPD in Sheffield. In this new study, the investigators will use Xenon gas MR imaging and 19F gas MR imaging to obtain physiological, structural, and functional information about patients with known respiratory disease, namely asthma and COPD. Up to 20 patients with asthma and up to 20 patients with COPD will be recruited. Study visits will involve lung function tests and imaging using proton MRI, hyperpolarised xenon gas MRI, and 19F perfluoropropane MRI. After initial baseline assessments, patients will be followed up after 3 and 6 years to investigate the utility of MRI and lung function measurements in tracking disease progression over time. In addition, during the COVID-19 pandemic will also be studying the long term effects of this novel disease. The investigators will use Xenon gas MR imaging and pulmonary vascular 1H MR imaging to obtain physiological, structural, and functional information about patients with COVID-19, including hospitalised patients and mild, non-hospitalised COVID-19 patients. Participants may be invited for baseline assessments during the symptomatic phase of the disease and/or be followed up after 6, 12, 24 and 52 weeks (in line with clinical follow up for hospitalised patients) to investigate long term effects of this novel disease. This novel approach will provide mechanistic insight in to clinical observations such as : (i) why previously healthy patients can respond so poorly to oxygen/ventilation therapy, (ii) why patients respond to proning, and (iii) whether this is caused by alveolar-capillary interstitial changes and /or microvascular clotting in the pulmonary vasculature (leading to V/Q mismatch), and (iv) whether these acute changes lead to long term interstitial lung disease.

Conditions

Asthma; COPD; Covid19; Long COVID

Outcome Measures

Primary Outcomes (1)

• %Ventilated volume

  a measurement derived from MRI images that quantifies the relative amount of lung that is ventilated, corrected for size.

  3-6 years for asthma/COPD patients, 3-12months for COVID-19 participants

Study Arms (6)

Asthma Patients

Adults with physician diagnosis of stable asthma (BTS guideline Step 3 or above).

COPD Patients

Adults with Stage 3 or 4 COPD (as defined by GOLD guideline 2018)

ICU COVID-19

Adults who have been hospitalised on ICU with COVID-19 (requiring CPAP or mechanical ventilation)

Moderate/Severe COVID-19

Adults hospitalised with COVID-19

Mild- Non-hospitalised COVID-19

Adult with proven COVID-19 infection, not hospitalised for COVID-19

Non-hospitalised symptomatic (long-COVID group)

Patients presenting at secondary care clinics post COVID-19 with ongoing symptoms.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthma/COPD/COVID-19

You may qualify if:

• Adults aged 18 years or over.
• Physician diagnosis of stable asthma (BTS guideline Step 3 or above).

You may not qualify if:

• Recent asthma exacerbation requiring steroids and/or antibiotics in the 6 weeks prior to a study visit.
• Asthma deemed by a physician to be unstable or in an active treatment modification phase.
• Pregnancy (determined by urine pregnancy test for pre-menopausal women at the screening (V1) or eligibility visits (V3, V5).
• Resting blood oxygen saturations (SaO2) \< 90% in room air, as measured by oximeter.
• Inability to comfortably lie supine.
• Any contraindication(s) to MRI scanning as per the MRI Screening Form and standard operating procedure used by the Unit of Academic Radiology, Sheffield.
• Disease or co-morbidity of sufficient severity as to make survival until 6 year follow up unlikely, as deemed by study clinician.
• COPD patients
• Adults aged 18 years or over.
• Stage 3 or stage 4 COPD as defined by GOLD guidelines 2018, (https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf) .
• FEV1:FVC \<0.7 (spirometry results).
• Recent COPD exacerbation requiring steroids and/or antibiotics in the 6 weeks prior to a study visit.
• COPD deemed by a physician to be unstable or in an active treatment modification phase, including the active phase of pulmonary rehabilitation.
• Pregnancy (determined by urine pregnancy test for pre-menopausal women at the screening (V1) or eligibility visits (V3, V5).
• Significant heart failure as assessed by clinician.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Academic Unit of Radiology, Univeristy of Sheffield

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Post-Infectious Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: September 4, 2019
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

GB (1)