Authorised Therapeutic use (Phase IV) Perianal fistula associated with Crohn's disease

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

EU CTIS ID: 2025-523278-18-00

What this study is testing

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

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • Age ˂18 years
  • Pregnancy and/or breastfeeding
  • Renal failure (GFR ˂30 ml/min in recent laboratory values up to 6 months old)
  • History of hypersensitivity reaction to gadolinium-containing contrast media
  • Patients with Crohn's disease without perianal disease

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.