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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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523278-18-00
Acronym
GadoCrohn
Enrollment
30
Registered
2025-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal fistula associated with Crohn's disease

Brief summary

The main variable to be analyzed is qualitative in nature and corresponds to the correct, verified detection of the perianal fistula tract in the magnetic resonance imaging study. This will be done by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team.

Detailed description

The secondary variables to be analyzed will enable a more exhaustive study of the use of contrast media in this type of pathology, in order to refine its use. The secondary variables are quantitative in nature and are as follows:, CNR (contrast-to-noise ratio) between different regions of interest in the fistulous tract and adjacent healthy tissue., Enhancement contrast percentage in different regions of interest of the fistulous tract before and after contrast medium administration.

Interventions

DRUGGadovist 1.0 mmol/ml solution for injection in prefilled cartridge

Sponsors

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The main variable to be analyzed is qualitative in nature and corresponds to the correct, verified detection of the perianal fistula tract in the magnetic resonance imaging study. This will be done by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team.

Secondary

MeasureTime frame
The secondary variables to be analyzed will enable a more exhaustive study of the use of contrast media in this type of pathology, in order to refine its use. The secondary variables are quantitative in nature and are as follows:, CNR (contrast-to-noise ratio) between different regions of interest in the fistulous tract and adjacent healthy tissue., Enhancement contrast percentage in different regions of interest of the fistulous tract before and after contrast medium administration.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026