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Status:

SUSPENDED

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

Lead Sponsor:

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborating Sponsors:

University of Sheffield

Conditions:

Asthma

COPD

Eligibility:

All Genders

18+ years

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 lun...

Detailed Description

For asthma and COPD patients, this is a feasibility study to explore the use of gas MRI lung imaging techniques in tracking disease progression over a 6 year time period. Participants will have a base...

Eligibility Criteria

Inclusion

  • Asthma patients
  • Inclusion criteria
  • Adults aged 18 years or over.
  • Physician diagnosis of stable asthma (BTS guideline Step 3 or above).
  • Exclusion criteria
  • 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
  • Inclusion criteria
  • 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).
  • FEV1 \< 50% predicted (spirometry results). N.B. spirometry results that have been performed as part of a patient's normal clinical care within 6 months of study visit 1 may be used for definition of disease status and inclusion into the study; alternatively if no spirometry result is available it will be performed at visit 1.
  • Exclusion criteria
  • 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.
  • 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 questionnaire 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.
  • ICU COVID-19
  • Inclusion criteria
  • Adult over 18
  • Proven COVID-19
  • Hospitalised/previously hospitalised on ICU requiring CPAP or mechanical ventilation
  • Able to give informed consent
  • For currently hospitalised participants, or those with significant on-going respiratory problems - Tolerates test inhalation of non-polarised gas according to supervising clinicians' judgement AND SaO2 do not fall below 80%
  • Exclusion criteria
  • No previous diagnosed respiratory disease with the exception of mild asthma, defined as:
  • no oral steroids in past year
  • -no hospital admissions last year
  • max 500mcg per day BDP or 250mcg fluticasone or equivalent ICS
  • Pregnancy (determined by urine pregnancy test for pre-menopausal women)
  • Significant heart failure as assessed by clinician.
  • Resting blood oxygen saturations (SaO2) \< 90%, as measured by oximeter at the time of scanning.
  • Inability to comfortably lie supine.
  • Any contraindication(s) to MRI scanning or Gadolinium contrast agent as per the MRI questionnaire and standard operating procedure used by the MRI Unit.
  • 6\. Stage 4 or 5 chronic kidney disease, defined by creatinine clearance less than 30 mL/min as estimated by the Cockcroft-Gault equation (due to gadolinium contrast use). 7. Previous allergy to gadolinium contrast. 8. Significant co-morbidity to make enrolment unsuitable, as deemed by study clinician.
  • Moderate/Severe COVID-19
  • Inclusion criteria
  • Adult over 18
  • Proven COVID-19
  • Hospitalised/previously hospitalised with a diagnosis of pneumonia (chest X-ray or CT scan consistent with COVID-19 infection)
  • Whilst hospitalised had new onset oxygenation impairment defined as:
  • a. An SpO2 ≤93% on room air and/or requiring additional oxygen to maintain satisfactory oxygenation
  • Able to give informed consent
  • For currently hospitalised participants, or those with significant on-going respiratory problems - Tolerates test inhalation of non-polarised gas according to supervising clinicians judgement AND SaO2 do not fall below 80%
  • Exclusion criteria
  • No previous diagnosed respiratory disease with the exception of mild asthma, defined as:
  • no oral steroids in past year
  • -no hospital admissions last year
  • max 500mcg per day BDP or 250mcg fluticasone or equivalent ICS
  • Pregnancy (determined by urine pregnancy test for pre-menopausal women)
  • Significant heart failure as assessed by clinician.
  • Resting blood oxygen saturations (SaO2) \< 90%, as measured by oximeter at time of MRI scanning.
  • Inability to comfortably lie supine.
  • Any contraindication(s) to MRI scanning or Gadolinium contrast agent as per the MRI questionnaire and standard operating procedure used by the MRI Unit.
  • Stage 4 or 5 chronic kidney disease, defined by creatinine clearance less than 30 mL/min as estimated by the Cockcroft-Gault equation (due to gadolinium contrast use).
  • Previous allergy to gadolinium contrast.
  • Significant co-morbidity to make enrolment unsuitable, as deemed by study clinician.
  • Mild- Non-hospitalised
  • Inclusion criteria
  • Adult over 18
  • Proven COVID-19
  • Not hospitalised for COVID-19
  • Able to give informed consent
  • Exclusion criteria
  • No previous diagnosed respiratory disease with the exception of mild asthma, defined as:
  • no oral steroids in past year
  • -no hospital admissions last year
  • max 500mcg per day BDP or 250mcg fluticasone or equivalent ICS
  • Pregnancy (determined by urine pregnancy test for pre-menopausal women)
  • Significant heart failure as assessed by clinician.
  • Resting blood oxygen saturations (SaO2) \< 90%, as measured by oximeter.
  • Inability to comfortably lie supine.
  • Any contraindication(s) to MRI scanning or Gadolinium contrast agent as per the MRI questionnaire and standard operating procedure used by the MRI Unit.
  • Stage 4 or 5 chronic kidney disease, defined by creatinine clearance less than 30 mL/min as estimated by the Cockcroft-Gault equation (due to gadolinium contrast use).
  • Previous allergy to gadolinium contrast.
  • Significant co-morbidity to make enrolment unsuitable, as deemed by study clinician.
  • Non-hospitalised symptomatic (long-COVID group)
  • Inclusion criteria
  • Adult over 18
  • Proven COVID-19
  • Not hospitalised for COVID-19
  • Able to give informed consent
  • Attended secondary care clinic with on-going symptoms.
  • Exclusion criteria
  • No previous diagnosed respiratory disease with the exception of mild asthma, defined as:
  • no oral steroids in past year
  • no hospital admissions last year
  • max 500mcg per day BDP or 250mcg fluticasone or equivalent ICS
  • Pregnancy (determined by urine pregnancy test for pre-menopausal women)
  • Significant heart failure as assessed by clinician.
  • Resting blood oxygen saturations (SaO2) \< 90%, as measured by oximeter at the time of scanning.
  • Inability to comfortably lie supine.
  • Any contraindication(s) to MRI scanning or Gadolinium contrast agent as per the MRI questionnaire and standard operating procedure used by the MRI Unit.
  • Stage 4 or 5 chronic kidney disease, defined by creatinine clearance less than 30 mL/min as estimated by the Cockcroft-Gault equation (due to gadolinium contrast use).
  • Previous allergy to gadolinium contrast.
  • Significant co-morbidity to make enrollment unsuitable, as deemed by study clinician.

Exclusion

    Key Trial Info

    Start Date :

    September 4 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2027

    Estimated Enrollment :

    160 Patients enrolled

    Trial Details

    Trial ID

    NCT04872309

    Start Date

    September 4 2019

    End Date

    August 1 2027

    Last Update

    December 18 2024

    Active Locations (1)

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    Academic Unit of Radiology, Univeristy of Sheffield

    Sheffield, South Yorkshire, United Kingdom, S10 2SJ