RecruitingOBSERVATIONAL

Diagnostic Concordance of MR Enterography and Ultrasound for Treatment Response Assessment in Crohn's Disease (MANTRA)

Living with Crohn's disease means dealing with ongoing inflammation in your gut. Doctors use powerful medicines to manage this, and it’s really important to know if these treatments are working. This study is called MANTRA and it's looking at two common scans: MR Enterography (a special type of MRI) and intestinal ultrasound. Both scans are used in the NHS to see inside your bowel safely and without surgery to check on your Crohn's. Currently, doctors don't have clear guidance on which scan to use or if they can be used interchangeably. This study aims to find out if these two scans give similar results when checking how well your treatment is working. This information will help doctors decide the best way to monitor Crohn's disease in the future, potentially offering more choices for patients.

At a glance

Status

Recruiting

Sponsor

University College, London

Enrolment target

155

Start

04 Oct 2024

Estimated completion

01 Oct 2026

Crohn Disease

What is this study about?

Crohn's disease causes inflammation in your digestive system, and treatments aim to reduce this inflammation. To make sure your treatment is doing its job, doctors regularly check your condition. While looking at your symptoms and doing blood or stool tests are helpful, they don't always give the full picture. More detailed scans, like MR Enterography (MRE) and intestinal ultrasound (IUS), allow doctors to see inside your gut. These scans are safe and don't involve surgery, making them common tools in the NHS for checking how your treatment is progressing.

At the moment, doctors don't have clear rules about when to use an MRE scan or an intestinal ultrasound, or if they can simply swap one for the other. This study wants to compare these two important scans directly. Researchers will ask people who are already having a follow-up scan for their Crohn's disease to have both an MRE and an intestinal ultrasound. Expert doctors will then look at these scans, without knowing the results of the other scan, to see if they show the disease is getting better or worse.

The information from this study will help us understand how accurate each scan is at checking treatment response and how often they agree with each other. This knowledge is really important because it will guide doctors on the best ways to monitor Crohn's disease in the future. For example, it might mean that patients could have more say in which scan they prefer, or it could help hospitals decide which scans to provide based on what's available and most practical.

Key takeaways

This study compares two common scans for Crohn's disease: MRE and intestinal ultrasound.
It aims to find out if both scans are equally good at checking if your treatment is working.
Participation involves having both scans during your regular check-ups.
The results will help doctors choose the best way to monitor Crohn's in the future.
You won't need to take new medicines or have extra appointments outside your usual care.
This research could offer more options for patients with Crohn's disease in the long run.

Who may be eligible?

This study is looking for volunteers aged 16 or older who have Crohn's disease affecting their small or large bowel. To join, you must have had either an MRE scan or an intestinal ultrasound in the past, before starting your current treatment. You should also be due for another MRE or intestinal ultrasound within 15 months of that first scan, as part of your regular check-ups to see if your treatment is working.

However, there are a few reasons why you might not be able to take part. This includes if you've recently had surgery to remove part of your bowel where the disease was. You also can't join if you're pregnant, if you have any health issues that make having an MRI scan unsafe for you, or if you're unable to give your full agreement to participate.

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.

Are you 16 years old or older?
Do you have Crohn's disease affecting your small or large bowel?
Have you had an MRE or intestinal ultrasound previously for your Crohn's?
Are you due for another MRE or intestinal ultrasound soon to check your treatment?
Are you not pregnant and don't have reasons making an MRI scan unsafe for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be asked to undergo both an MR Enterography (MRE) scan and an intestinal ultrasound (IUS) scan. These will be done as part of your regular visit to check on your Crohn's treatment, so you won't need extra appointments beyond these two scans. Doctors who are experts in reading these scans will then look at your results to see how your disease is responding to treatment. The overall duration of your participation will depend on when you have these two scans, but it's built around your standard medical care.

Potential risks and benefits

Taking part in this study could help future patients with Crohn's disease by improving how we monitor treatment. You won't receive direct medical benefits from being in the study, but you'll be contributing to important research. The MRE and IUS scans are generally safe, but like any medical procedure, there are small risks, which your doctor will explain. For example, an MRE uses strong magnets and some people cannot have them. You are free to change your mind and withdraw from the study at any time 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 College London Hospitals
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a condition that causes inflammation in your digestive system, which can lead to symptoms like tummy pain, diarrhoea, and weight loss.

What is an MRE scan?

An MRE (MR Enterography) is a special type of MRI scan that takes pictures of your small bowel to help doctors see inflammation and other issues.

What is an intestinal ultrasound?

An intestinal ultrasound uses sound waves to create images of your bowel, helping doctors check for inflammation without using radiation.

Will I have to take new medicine?

No, this study does not involve taking new medications. It's about comparing how well two types of scans work to check on your current treatment.

Will this study change my doctors' decisions about my care?

The results of your scans will still be used by your doctors to make decisions about your treatment, just as they would normally. The study is comparing the scans themselves.

How to find out more

Maira Hameed

maira.hameed@ucl.ac.uk 020 7679 9274 Official trial record

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