Gadopiclenol for Perianal fistula associated with Crohn's disease

Inclusion criteria

• {"criterion_text":"-Patients of legal age with Crohn's disease and perianal disease attributable to their condition"}
• {"criterion_text":"-Subjects with onset of Crohn's disease with perianal disease"}
• {"criterion_text":"-Sign informed consent"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Correct detection of the perianal fistula tract on MRI by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team."}

Secondary endpoints

• {"endpoint_text":"-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:","definition_or_measurement_approach":"General descriptor that secondary variables are quantitative measures to study contrast media use; specific measurement approaches listed in subsequent endpoints."}
• {"endpoint_text":"-CNR (contrast-to-noise ratio) between different regions of interest in the fistulous tract and adjacent healthy tissue.","definition_or_measurement_approach":"Measurement of contrast-to-noise ratio between regions of interest in the fistulous tract and adjacent healthy tissue on MRI images."}
• {"endpoint_text":"-Enhancement contrast percentage in different regions of interest of the fistulous tract before and after contrast medium administration.","definition_or_measurement_approach":"Calculation of enhancement contrast percentage in specified regions of interest of the fistulous tract comparing pre- and post-contrast MRI images."}

Spain

Earliest CTIS Part Ii Submission Date

19-11-2025

Latest Decision Or Authorization Date

18-12-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain