Magnetic resonance lung imaging using hyperpolarised gas for cystic fibrosis

MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis

This project tests advanced lung imaging with hyperpolarised xenon MRI together with multiple breath washout in people with cystic fibrosis to see if they reveal lung changes over time.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (Academic / other)
• Locations: 1 site (Sheffield)
• Trial ID: NCT07192679 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People with a confirmed clinical diagnosis of cystic fibrosis (two CFTR mutations plus supporting clinical or sweat chloride evidence), able to attend the local Sheffield MRI unit, and meeting the study age and lung function criteria are ideal candidates.

Not a fit: Patients with very low lung function (FEV1 ≤30% predicted), those who cannot undergo MRI (e.g., incompatible implants or severe claustrophobia), or those unable to travel to Sheffield are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could detect lung changes earlier or more precisely than current routine tests, helping clinicians tailor care sooner.

How similar studies have performed: Prior research using hyperpolarised gas MRI and MBW has shown promise for detecting early or regional lung changes in cystic fibrosis, but these techniques remain relatively new and are still being validated for routine clinical use.

Eligibility criteria

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 this trial is running

Sheffield

• University of Sheffield MRI Unit — Sheffield, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Jim Wild, Professor

Conditions Cystic Fibrosis