Magnetic resonance lung imaging using hyperpolarised gas for cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses hyperpolarised 129Xe MRI (HP MRI) and multiple breath washout (MBW) alongside standard lung function tests to capture detailed measures of lung ventilation and clearance. Participants undergo same-day imaging and breathing tests to compare how these measurements relate and change over time. The study includes several cohorts by age and prior participation (including a cohort of children aged 1–5 years for proton MRI and participants aged 5+ for 129Xe MRI and MBW), and is conducted at a single regional centre. No investigational drugs are given; the focus is on advanced measurement techniques to better characterize lung function in cystic fibrosis.

Why it matters

Who can join: the full rules

General Inclusion criteria

For eligibility into MAGNIFY, subjects should meet all of the following criteria:

1. 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.
2. Be able to attend the local facility for scans (Royal Hallamshire Hospital, Sheffield).

For eligibility into 129Xe-MRI and lung function (cohort 1,2 and 3)

1. Aged 5 years and above
2. FEV1 \>30% predicted (best in the previous 6 months) For eligibility for cohort 1

1\. Previous participation in the MMAVIC study, with at least one prior visit where lung ventilation MRI was successfully measured.

For eligibility into cohort 4 for 1H MRI only:

1\. Aged between 1 and 5 years of age

General Exclusion criteria

Patients who meet any of the following criteria will be excluded from the study. Further exclusions may be applied at the discretion of the principal investigators.

1. Previous lung transplant.
2. Infection with organisms of the Burkholderia cepacia complex, MRSA or Mycobacterium abscessus.
3. Pregnancy.
4. Resting SpO2 \< 90% in room air.
5. Inability to comfortably lie supine for more than 60 minutes.
6. Any contraindication(s) to MRI scanning as per the MRI questionnaire used in clinical practice by the University of Sheffield MRI unit, Royal Hallamshire Hospital.

Research visit (temporary) exclusion criteria

1. Pulmonary exacerbation within 4 weeks as defined by no new treatments in that time, no clinically significant change in their symptoms or spirometry (as judged by attending physician).
2. Pregnancy. Patients who become pregnant prior to consent or during the study can remain in the study. However, no research visits will take place during pregnancy.

Where it's running

• University of Sheffield MRI Unit
  Sheffield, United Kingdom Recruiting

Study contacts

• Study coordinator: Jim Wild, Professor
• Email: sth.magnifystudy@nhs.net
• Phone: 01142159595

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.