AuthorisedTherapeutic use (Phase IV)Interventional

Phase IV, single-center, randomized, crossover clinical trial to validate the use of gadopiclenol versus gadobutrol in the evaluation of magnetic resonance imaging (MRI) diagnosis of perianal fistula associated with Crohn's disease

This study is looking at two different special dyes, called contrast agents, that are used during MRI scans. The aim is to see which dye helps doctors get a clearer picture of perianal fistulas in people who have Crohn's disease. Perianal fistulas are small tunnels that can form near the bottom, and seeing them clearly on an MRI helps doctors understand them better and plan the right treatment. Participants will have MRI scans using both dyes at different times, so doctors can compare how well each dye shows the fistula. This information will help improve how we diagnose and manage this condition in the future.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Enrolment target

Start

18 Dec 2025

Perianal fistula associated with Crohn's disease

What is this study about?

This study is aimed at helping doctors get the best possible pictures when performing an MRI scan on particular patients. If you have Crohn's disease, you might sometimes develop a condition called a perianal fistula. This is a small tunnel or tract that forms under the skin near your bottom. Doctors often use a special type of scan called an MRI to look at these fistulas, as it helps them understand how big they are, where they go, and how best to treat them.

To make the MRI pictures even clearer, doctors often use a special liquid, called a contrast agent or dye, which is given into a vein before the scan. This dye helps certain parts of the body stand out on the MRI image. This study is comparing two different contrast dyes, Elucirem and Gadovist, to see which one does a better job at highlighting these perianal fistulas during an MRI scan.

The main goal is to find out which dye helps doctors most accurately see and understand the fistula on the MRI. By finding this out, doctors can choose the best dye to use, which could lead to more accurate diagnoses and better treatment plans for people with Crohn's disease and perianal fistulas.

Key takeaways

Compares two MRI dyes for perianal fistulas in Crohn's patients.
Aims to find the best dye for clear fistula imaging.
Involves two MRI scans, each with a different dye.
Could improve future diagnosis and treatment for this condition.
Open to adults aged 18 and over with Crohn's-related perianal fistula.

Who may be eligible?

This study is looking for adults aged 18 or over. There's no upper age limit, so people of all adult ages can take part.

Both men and women are welcome to join this study, as the condition and the MRI scans are relevant to everyone.

To be eligible, you must have a perianal fistula linked to Crohn's disease. Your doctors will check if you meet all the other specific health requirements for taking 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.

Are you 18 years old or older?
Do you have Crohn's disease?
Do you have a perianal fistula (a tunnel near your bottom) linked to your Crohn's?
Are you able to have 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 have two main study visits at the hospital. These visits will be spread out, not on consecutive days. During each visit, you will have an MRI scan of your perianal area. Before each scan, you will be given one of the two special dyes (either Elucirem or Gadovist) through a small tube in your arm. You won't know which dye you're getting at each visit, and they will be swapped around so you receive both dyes overall across the two visits.

After each MRI scan, the study doctors will carefully look at the images to see how clearly the perianal fistula shows up. You'll also have a follow-up appointment or contact after your scans to check on your well-being. The study will last for a short period, covering these few visits.

Potential risks and benefits

Taking part in this study could help improve how doctors diagnose and treat perianal fistulas in the future, benefiting others with Crohn's disease. You might also get a very detailed assessment of your own fistula. However, there are some potential risks, like mild reactions to the contrast dye, such as feeling warm, dizzy, or having a rash, though serious reactions are rare. MRI scans involve strong magnetic fields, which are generally safe but might not be suitable for people with certain metal implants. You can stop taking part in 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.

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Unverified
Spain

Common questions

What is a 'perianal fistula'?

It's a small tunnel that can form under the skin near your bottom, often linked to Crohn's disease.

What is an 'MRI scan'?

It's a special type of scan that uses strong magnets and radio waves to create detailed pictures inside your body.

What are 'contrast dyes'?

These are special liquids given before an MRI to help certain parts of your body show up more clearly on the scan.

Will I know which dye I'm getting?

No, you won't know at each visit; it's chosen randomly, and you will get both dyes across your study visits.

How long will the study last for me?

It will involve a few visits to the hospital over a short period of time.

How to find out more

Official trial record

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