MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis

NCT07192679 | Recruiting

• 1 other identifier: STH22784
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis (CF)

Outcome Measures

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.

  Up to 3 years, depending on cohort.

Secondary Outcomes (6)

• XeMRI outcome measures - Ventilation Heterogeneity Index

  up to 3 years

• XeMRI outcome measures - individual defects

  up to 3 years

• XeMRI outcome measures - reversibility index

  up to 3 years

• Lung function metrics - LCI

  Up to 3 years

• Lung function metrics - Scond (from MBW).

  Up to 3 years

Study Arms (5)

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.

Cohort 5 - MRI repeatability

Adult participants will be recruited to have repeat MRI scans at various field strengths at 3 sites to assess repeatability of measures.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children with cystic fibrosis

You may qualify if:

• 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
• \. 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:
• \. Aged between 1 and 5 years of age

You may not qualify if:

• Previous lung transplant.
• Infection with organisms of the Burkholderia cepacia complex, MRSA or Mycobacterium abscessus.
• Pregnancy.
• Resting SpO2 \< 90% in room air.
• Inability to comfortably lie supine for more than 60 minutes.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

University of Sheffield MRI Unit

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Jim Wild, Professor

CONTACT

01142159595; sth.magnifystudy@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 25, 2025
• Study Start: February 21, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)