MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis

Recruiting

• Conditions: Cystic Fibrosis (CF)

• Registration Number: NCT07192679
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilation defect percent (VDP) as measured by 129Xe-MRI	Up to 3 years, depending on cohort.	The primary endpoint will be changes in the 129Xe-MRI metric; ventilation defect percent (VDP) between study visits.

Secondary Outcome Measures

Name	Time	Method
XeMRI outcome measures - Ventilation Heterogeneity Index	up to 3 years	Similar analysis to the primary outcome will be conducted for Ventilation Heterogeneity Index (VHI)
XeMRI outcome measures - individual defects	up to 3 years	Similar analysis to the primary outcome will be conducted for the number and size (single measure) of individual defects
XeMRI outcome measures - reversibility index	up to 3 years	Similar analysis to the primary outcome will be conducted for reversibility index.
Lung function metrics - LCI	Up to 3 years	Similar analysis will be conducted for the major lung function test metric - LCI, Scond, Sacin (from MBW).; R5, R5-R20, X5 and Ax from AOS. RV/TLC from body plethysmography. FEV1, FEV1/FVC from spirometry.
Lung function metrics - Scond (from MBW).	Up to 3 years	Similar analysis will be conducted for the major lung function test metric - Scond, an outcome marker measured from MBW that represents ventilation heterogeneity in the conducting airways within the lung.; R5, R5-R20, X5 and Ax from AOS. RV/TLC from body plethysmography. FEV1, FEV1/FVC from spirometry.
Lung function metrics - Sacin (from MBW).	Up to 3 years	Similar analysis will be conducted for the major lung function test metric - Sacin, an outcome marker measured from MBW that represents ventilation heterogeneity in the acinar airways within the lung.; R5, R5-R20, X5 and Ax from AOS. RV/TLC from body plethysmography. FEV1, FEV1/FVC from spirometry.

Trial Locations

Locations (1)

University of Sheffield MRI Unit; 🇬🇧 Sheffield, United Kingdom