NCT07192679 MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis
| NCT ID | NCT07192679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Cystic Fibrosis (CF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-02-21 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07192679 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07192679 currently recruiting?
Yes, NCT07192679 is actively recruiting participants. Contact the research team at sth.magnifystudy@nhs.net for enrollment information.
Where is the NCT07192679 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT07192679 clinical trial?
NCT07192679 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 60 participants.