MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis
ConditionCystic Fibrosis (CF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorSheffield Teaching Hospitals NHS Foundation Trust
About this trial
This research study is looking at new ways of measuring the function of the lungs in patients with cystic fibrosis. This study is using the most advanced methods for measuring lung function including 2 tests called hyperpolarised gas magnetic resonance imaging (HP MRI) and multiple breath washout (MBW), to better understand changes in the lungs over time.
HP MRI involves taking pictures of the air in your lungs after breathing in a harmless gas (xenon). MBW is a breathing test used to calculate something called the lung clearance index (LCI).
By measuring these tests on the same day, alongside standard lung function tests, we aim to understand lung function in greater detail than ever before.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A confirmed clinical diagnosis of CF, consisting of 2 confirmed disease-causing CFTR mutations along with either positive sweat chloride (>60mmol/L, measured before starting CFTR modulator therapy) or a clinical picture consistent with CF as judged by a senior CF physician. Patients will be under one of named regional CF centres above.
Be able to attend the local facility for scans (Royal Hallamshire Hospital, Sheffield).
Aged 5 years and above
FEV1 >30% predicted (best in the previous 6 months) For eligibility for cohort 1
Disqualifiers
Previous lung transplant.
Infection with organisms of the Burkholderia cepacia complex, MRSA or Mycobacterium abscessus.
Pregnancy.
Resting SpO2 < 90% in room air.
Trial population
Adults and children with cystic fibrosis
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 5 trial groupsGroup A: Cohort 1 - MMAVIC protocol
Group B: Cohort 2: Patients not eligible for HEMT
Group C: Cohort 3: School-age children on standard of care treatment
Group D: Cohort 4: Pre-school children on standard of care treatment
Group E: Cohort 5 - MRI repeatability
Trial outcomes
Primary outcomes
1
Ventilation defect percent (VDP) as measured by 129Xe-MRI
The primary endpoint will be changes in the 129Xe-MRI metric; ventilation defect percent (VDP) between study visits.
Time frame
Up to 3 years, depending on cohort.Secondary outcomes
1
XeMRI outcome measures - Ventilation Heterogeneity Index
Similar analysis to the primary outcome will be conducted for Ventilation Heterogeneity Index (VHI)
Time frame
up to 3 years2
XeMRI outcome measures - individual defects
Similar analysis to the primary outcome will be conducted for the number and size (single measure) of individual defects
Time frame
up to 3 years3
XeMRI outcome measures - reversibility index
Similar analysis to the primary outcome will be conducted for reversibility index.
Time frame
up to 3 years4
Lung function metrics - LCI
Similar analysis will be conducted for the major lung function test metric - LCI, Scond, Sacin (from MBW). R5, R5-R20, X5 and Ax from AOS. RV/TLC from body plethysmography. FEV1, FEV1/FVC from spirometry.
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
University of Sheffield
Collaborator
Source ClinicalTrials.gov