MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
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⁃ For eligibility into MAGNIFY, subjects should meet all of the following criteria:

• 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).

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

• Aged 5 years and above

• 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

Locations
Other Locations
United Kingdom
University of Sheffield MRI Unit
RECRUITING
Sheffield
Contact Information
Primary
Jim Wild, Professor
sth.magnifystudy@nhs.net
01142159595
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 80
Treatments
Cohort 1 - MMAVIC protocol
Twenty patients who previously participated in the MMAVIC study, eligible to be on the new regime of CF therapies. These patients will be recruited and invited to attend 4 visits over 3 years.
Cohort 2: Patients not eligible for HEMT
A combination of approximately ten children and ten adults who are either not eligible to take HEMT or have not tolerated highly effective modulator treatment (HEMT). Previous MMAVIC participants not on HEMT are also eligible for this cohort. These patients will be invited to attend 3 visits over 2 years.
Cohort 3: School-age children on standard of care treatment
Twenty children who are receiving the current standard of care treatment, including HEMT or other CFTR modulators. These patients will be invited to attend 2 visits - 1 year apart.
Cohort 4: Pre-school children on standard of care treatment
Up to 20 children under the age of 5 years, who are receiving the current standard of care, including CFTR modulator therapies. These participants will have a single visit.
Related Therapeutic Areas
Sponsors
Collaborators: University of Sheffield
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov