Active not recruitingPHASE4INTERVENTIONAL

Hyperpolarized Imaging for New Treatments

This study, called HyPOINT, explores better ways to measure lung health in people with cystic fibrosis, especially when starting new high-impact treatments. It uses a special type of MRI scan, called hyperpolarized imaging, which uses a harmless gas to show how air flows in the lungs. This scan is safe and doesn’t use radiation, making it good for repeated checks. Researchers want to see if these new scans can detect early lung changes and show how effective new CF medicines are, even when people don't have many symptoms yet. This research aims to help develop more tailored treatments for CF in the future.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrolment target

Start

13 Jan 2020

Estimated completion

31 Dec 2026

Cystic Fibrosis

What is this study about?

Cystic fibrosis (CF) is an inherited condition that causes sticky mucus to build up in the lungs and other organs. New treatments, called CFTR modulators, are making a big difference for many people with CF, often improving their health significantly. However, it can be hard to tell how well these new medicines are working, especially in the early stages or for people who don't have severe symptoms yet. We also need better ways to track lung health over time.

This is where the HyPOINT study comes in. Researchers are investigating a new way to look at the lungs using a special type of MRI scan. Unlike a regular X-ray or CT scan, this MRI uses a harmless gas that you breathe in. This allows doctors to see how air moves through your lungs, giving a detailed picture of their function. This is important because it might show very small changes in the lungs that current tests might miss. Because it doesn't use radiation, it's also safer for people to have these scans more often.

The main goal of the HyPOINT study is to see how useful these special MRI scans are. They want to find out if these scans can accurately detect early lung problems in people with CF, measure how well new medicines are working, and track changes in lung health over time. This research is a really important step towards making CF treatments even more personalised and effective for everyone, including those with rarer forms of the condition.

Key takeaways

New MRI scans are being tested to monitor lung health in CF.
The scans use a harmless gas and no radiation, making them safe for repeated use.
Aims to detect early lung changes and how well new CF medicines work.
Could lead to more personalised CF treatments in the future.
Study participants will have special MRI scans in a research setting.

Who may be eligible?

This study is looking for young people with cystic fibrosis. To take part, you need to be between 6 and 18 years old, depending on which part of the study you join. You must have a confirmed diagnosis of CF and have the F508del gene mutation (or one copy of it).

It's important that you are feeling well and haven't had any recent antibiotics or changes to your regular CF medicines in the last few weeks. You also need to be able to comfortably lie still for an MRI scan and follow the study instructions.

There are some reasons why you might not be able to join, such as having certain metal implants, being pregnant or breastfeeding, or if the doctors feel it wouldn't be safe or helpful for you to take part.

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.

I am between 6 and 18 years old.
I have been diagnosed with cystic fibrosis (CF).
I have at least one copy of the F508del CF gene change.
I am feeling well and haven't had recent antibiotics or changed my CF medicines.
I am able to lie still for an MRI scan.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll visit one of the study centers. For the first part of the study, you'll have a special MRI scan where you breathe in a harmless gas. You'll have this scan multiple times on the same day, and then again about a month later. We'll check your vital signs like heart rate and oxygen levels before, during, and after the scans to make sure you're comfortable.

For the second part of the study, if you're starting a new triple combination CF medicine, you'll have the special MRI scan before you start the medicine and again about a month after. We'll also keep track of any side effects you might experience. Overall, your participation would involve several visits and MRI scans over a period of roughly one month for each phase you join.

Potential risks and benefits

Participating in this study might offer some potential benefits, as it contributes to advancing our understanding of cystic fibrosis and developing better ways to monitor its treatment. You would receive state-of-the-art lung imaging. However, this study is primarily for research purposes, so there might not be a direct personal benefit to you. Potential risks are generally low. The special MRI scan uses a harmless gas, and your vital signs will be closely watched during the procedure. As with any medical procedure, there's always a small chance of unexpected discomfort or rare side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Cincinnati Children's Hospital Medical Center
Verified postcode
Cincinnati, United States
University of Virginia School of Medicine
Verified postcode
Charlottesville, United States
University of Wisconsin
Verified postcode
Madison, United States
The Hospital for Sick Kids
Verified postcode
Toronto, Canada

Common questions

What is hyperpolarized imaging?

It's a special type of MRI scan that uses a harmless gas you breathe in. This allows doctors to see how air moves in your lungs, giving detailed information about your lung function.

Is the special MRI scan safe?

Yes, it uses a harmless gas and doesn't involve radiation. Your heart rate and oxygen levels will be carefully monitored throughout the scan.

Will I get new medicine during this study?

No, this study doesn't provide new medicine. For the second part, we observe patients who are starting new triple combination CF medicines as part of their regular care.

How long will I need to be in the study?

If you join, your involvement for each phase would typically be over about a month, including several visits to the study centre for scans.

Why is this study important?

It helps researchers understand how to better measure changes in lung health in people with CF. This could lead to more personalised and effective treatments in the future.