MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis

NCT ID: NCT07192679

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2028-01-01

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)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

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.

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.

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Sheffield MRI Unit

Sheffield, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jim Wild, Professor

Role: CONTACT

sth.magnifystudy@nhs.net

01142159595

Facility Contacts

Demi-Jade Jakymelen

Role: primary

sth.magnifystudy@nhs.net

01142159595

Other Identifiers

STH22784

Identifier Type: -

Identifier Source: org_study_id