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
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
- Diseases
- Crohn's disease
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.