RecruitingOBSERVATIONAL

MAGNIFY - Pulmonary Magnetic Resonance Imaging for Cystic Fibrosis

This research is looking for new and better ways to measure how well the lungs are working in people with cystic fibrosis (CF). Researchers are using advanced techniques like 'hyperpolarised gas MRI' (a special lung scan after breathing a harmless gas) and a breathing test called 'multiple breath washout' (MBW) to get a very detailed picture of lung health. These new tests are done alongside the usual lung function checks. The goal is to understand lung changes in CF over time much more clearly, which could lead to better ways to monitor and treat the condition. The study is open to men and women aged 1 year and older who have a confirmed diagnosis of CF.

At a glance

Status

Recruiting

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

21 Feb 2024

Estimated completion

30 Jun 2029

Cystic Fibrosis (CF)

What is this study about?

This study, called MAGNIFY, is all about finding better ways to understand how the lungs are working in people with cystic fibrosis (CF). Currently, doctors use standard tests to check lung function, but this research wants to dive deeper. They're using some very advanced tools to get a more detailed picture than ever before.

Two of the main tools being used are special scans and breathing tests. One is called 'hyperpolarised gas magnetic resonance imaging' or HP MRI. This is like a very advanced scan that takes pictures of the air inside your lungs after you've breathed in a harmless gas. The other is a breathing test called 'multiple breath washout' or MBW. This test helps calculate something called the 'lung clearance index' (LCI), which gives doctors information about how well air moves in and out of your lungs.

By carefully checking these new measurements at the same time as the usual lung tests, the researchers hope to learn much more about how CF affects the lungs over time. This deeper understanding could be really important for developing better ways to monitor CF and even improve future treatments. It's about getting a clearer, more complete picture of lung health in people with CF.

Key takeaways

The study aims to find better ways to measure lung health in CF.
It uses advanced scans (HP MRI) and breathing tests (MBW).
It's for people with CF aged 1 year and older.
Participation involves visits to the Royal Hallamshire Hospital in Sheffield.
You won't get direct personal health benefits from joining.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you need to have a confirmed diagnosis of cystic fibrosis. This means doctors have either found two specific gene changes related to CF and a high salt level in your sweat, or a senior CF doctor has agreed that your symptoms match CF. You also need to be able to travel to the Royal Hallamshire Hospital in Sheffield for your study visits.

If you're aged 5 or older, your lung function (measured by a test called FEV1) should be above a certain level (more than 30% of what's expected) in the last six months. They are also looking for very young children, aged 1 to 5 years old, for a specific part of the study that only involves a certain type of MRI scan. Some people who took part in a previous study called MMAVIC might also be eligible.

However, some things would mean you can't join the study. This includes if you've had a lung transplant, if you have certain types of infections (like Burkholderia cepacia complex, MRSA, or Mycobacterium abscessus), or if you are pregnant. You also can't take part if your oxygen levels are very low, if you can't lie flat for about an hour, or if you have any metal in your body that would make an MRI scan unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of cystic fibrosis?
Am I able to travel to the Royal Hallamshire Hospital in Sheffield?
Am I aged 1 year or older?
Have I had a lung transplant? (If yes, you likely can't join)
Am I pregnant? (If yes, you likely can't join for visits)
Do I have any metal in my body that would make an MRI unsafe?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the Royal Hallamshire Hospital in Sheffield. During your visit, you'll have several tests done. These will include standard lung function tests, the special hyperpolarised gas MRI scan (where you breathe a harmless gas for pictures of your lungs), and the multiple breath washout (MBW) breathing test. You'll likely need to lie still for about an hour during the MRI scan.

These tests will all be done on the same day. The study is looking at how your lung function changes over time, but the specific number of visits and the total duration of your participation aren't fully detailed here. It's important to note that if you become pregnant during the study, you can remain involved, but no study visits will happen while you are pregnant. If you have a flare-up of your CF symptoms (a 'pulmonary exacerbation') within four weeks of a planned visit, that visit would need to be rescheduled.

Potential risks and benefits

Taking part in this study won't directly improve your health but could help doctors learn more about CF, which might lead to better care for other people in the future. The main potential risks are related to the MRI scan, such as discomfort from lying still, and any general risks associated with MRI (which will be checked by a questionnaire). The gas used in the HP MRI is harmless. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Sheffield MRI Unit
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is cystic fibrosis (CF)?

Cystic fibrosis is a genetic condition that mainly affects the lungs and digestive system, causing sticky mucus to build up and block passageways.

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body without using X-rays.

Will I have to breathe in any strange gases?

Yes, for one of the special lung scans (HP MRI), you will breathe in a small amount of a harmless gas called xenon, which helps create clearer pictures of your lungs.

How long will a study visit take?

The information suggests you'll need to lie still for over 60 minutes for the MRI, and other tests will be done on the same day, so a visit will likely take a few hours.

Will taking part in the study improve my CF?

This study is for research purposes to learn more about CF; it's not designed to directly treat your condition or give you immediate personal benefit.

How to find out more

Jim Wild, Professor

sth.magnifystudy@nhs.net 01142159595 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.