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Comparing Gadopiclenol and Gadobutrol MRI Scans for Detecting Perianal Fistulas in Patients with Crohn's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people who have Crohn's disease with a condition called perianal fistula, which is an abnormal connection or tunnel that forms near the area around the anus and is related to their Crohn's disease. The study will compare two different contrast agents, which are special liquids injected into a vein to help make images clearer during scans. The two contrast agents being tested are gadopiclenol, which is found in a product called Elucirem, and gadobutrol, which is found in a product called Gadovist. Both of these substances contain a metal called gadolinium that helps doctors see internal body structures more clearly on scans.

The purpose of this study is to check if gadopiclenol works well for finding and tracking perianal fistulas when used during magnetic resonance imaging, which is also called MRI, a type of scan that uses magnets and radio waves to create detailed pictures of the inside of the body. Participants will receive both contrast agents at different times during the study, with each one being given through a vein before an MRI scan is performed. The study follows a crossover design, which means that each person will have scans with both contrast agents so that doctors can compare how well each one works in showing the fistula tract, which is the path or tunnel of the abnormal connection.

During the study, doctors will look at the MRI images to see how clearly they can identify the perianal fistula when each contrast agent is used. They will also measure technical aspects of the images, such as how much difference there is between the fistula and the healthy tissue around it, and how much the contrast agent brightens the fistula area compared to before it was given. This information will help determine if gadopiclenol is as effective as gadobutrol for this specific use in people with Crohn's disease and perianal fistulas.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First magnetic resonance imaging scan

    You will undergo a magnetic resonance imaging scan (also called MRI) to examine the area around the anus where the fistula is located. A fistula is an abnormal tunnel that forms between the inside of the intestine and the skin.

    During this scan, you will receive an injection of a contrast medium called gadopiclenol. A contrast medium is a substance that helps make the images clearer so that the fistula can be seen better.

    The dose of gadopiclenol will be 0.05 mmol per kilogram of your body weight. This means the amount will be calculated based on how much you weigh.

    The contrast medium will be given through a vein in your arm, which is called intravenous administration.

  2. Step 2

    Waiting period between scans

    After the first scan, there will be a period of time before the second scan takes place.

    This waiting period allows your body to completely clear the first contrast medium before receiving the second one.

  3. Step 3

    Second magnetic resonance imaging scan

    You will undergo a second magnetic resonance imaging scan of the same area around the anus.

    During this scan, you will receive an injection of a different contrast medium called gadobutrol.

    The gadobutrol will also be given through a vein in your arm.

    The study will compare the results from both contrast media to determine which one provides better images for detecting and monitoring the fistula.

  4. Step 4

    Image analysis

    The images from both scans will be examined to see how well each contrast medium shows the fistula tract. The fistula tract is the tunnel or pathway that the fistula creates.

    The quality of the images will be measured by looking at how clearly the fistula can be seen compared to the surrounding healthy tissue.

    The analysis will also measure the contrast-to-noise ratio, which indicates how well the fistula stands out from the background in the images.

    The percentage of enhancement will be measured, which shows how much brighter the fistula appears after the contrast medium is given compared to before.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older to participate in this study
  • You must have been diagnosed with Crohn's disease, which is a long-term condition that causes inflammation in the digestive system
  • You must have perianal disease, which means you have problems in the area around the opening where bowel movements pass, and this must be related to your Crohn's disease
  • You must have perianal fistulas, which are abnormal tunnels or connections that form between the inside of the bowel and the skin near the anal area
  • You must be willing and able to sign an informed consent form, which is a document that explains the study and confirms you agree to take part
  • Both men and women can participate in this study

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the provided information.
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Investigated drugs

  • Gadopiclenol

    is a contrast agent used during magnetic resonance imaging (MRI) scans. This medication is injected into your body to help make certain areas, like perianal fistulas, show up more clearly on the MRI pictures. It works by improving the quality of the images so doctors can better see and evaluate the condition being studied.

  • Gadobutrol

    is also a contrast agent used during MRI scans. Like gadopiclenol, this medication is injected into your body to help create clearer and more detailed images during the scan. It helps doctors see specific areas of concern more easily so they can make a more accurate diagnosis of perianal fistulas.

What is already known about the treatment

  • Gadopiclenol

    Gadopiclenol is a contrast agent administered intravenously that is used during magnetic resonance imaging (MRI) scans to help doctors see internal body structures more clearly. This medication is currently being studied in clinical trials to determine its effectiveness in detecting and monitoring perianal fistulas, which are abnormal tunnels that form near the anal area in patients with Crohn's disease. Gadopiclenol works by temporarily changing the magnetic properties of tissues where it accumulates, making these areas appear brighter on MRI images and allowing doctors to better identify inflamed or abnormal tissues. It belongs to a class of medications called gadolinium-based contrast agents, which are commonly used in medical imaging to improve the quality and accuracy of diagnostic scans.

  • Gadobutrol

    Gadobutrol is an intravenous contrast agent used during magnetic resonance imaging (MRI) procedures to enhance the visibility of blood vessels, organs, and abnormal tissues in the body. This medication is already approved and widely used in medical practice for various diagnostic imaging purposes, including the evaluation of fistulas and inflammatory conditions. Gadobutrol works by altering the magnetic signals from body tissues where it is present, creating a stronger contrast between normal and abnormal areas on MRI scans, which helps physicians make more accurate diagnoses. It is classified as a gadolinium-based contrast agent, a standard type of imaging medication that has been used safely in millions of patients worldwide.

Investigated diseases

Perianal Fistula in Crohn's Disease – A perianal fistula is an abnormal tunnel that forms between the anal canal and the skin around the anus. This condition occurs as a complication in people who have Crohn's disease, which is a long-term inflammatory condition affecting the digestive tract. The fistula develops when inflammation from Crohn's disease creates a pathway through the tissues near the anus. Fluid or pus may drain from the opening on the skin, causing discomfort and irritation. The fistula can be a single tract or may branch into multiple pathways through the surrounding tissue. This complication significantly affects the quality of life and requires ongoing medical attention to manage the inflammation and drainage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523278-18-00Protocol codeGadoCrohnEstimated enrolment30 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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