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2025-523278-18-00Not yet recruitingPhase 4

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Dec 2025

Next steps

Brief summary (registry, in English)

To validate the use of 0.05 mmol/kg of Gadopiclenol in the detection and monitoring of perianal fistulas by magnetic resonance imaging studies.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
30 (estimated)
First submitted
3 Sept 2025
Start date
1 Dec 2025
Lead sponsor
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
EU CT number
2025-523278-18-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 30
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who also have a perianal fistula (a tunnel near the anus) caused by it. It compares two MRI contrast agents.

Age
18 years or older
Sex
All sexes can join
Disease stage
Crohn's disease with perianal disease caused by it

Main reasons for not taking part

  • Younger than 18 years
  • Pregnant or breastfeeding
  • Kidney failure (GFR below 30 ml/min in lab results up to 6 months old)
  • Past allergic reaction to gadolinium contrast media
  • Crohn's disease without perianal disease

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of hypersensitivity reaction to gadolinium-containing contrast media
  • Patients with Crohn's disease without perianal disease

Lab values

  • Renal failure (GFR ˂30 ml/min in recent laboratory values up to 6 months old)

Age

  • Age ˂18 years

Other

  • Pregnancy and/or breastfeeding

Who the study is looking for

  • Patients of legal age with Crohn's disease and perianal disease attributable to their condition
  • Subjects with onset of Crohn's disease with perianal disease
  • Sign informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'HebronBarcelonaSpainNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.