Crohn's disease inflammatory bowel disease
Conditions
Interventions
No investigational product and/or intervention is being investigated or used as a control in this study.
Sponsors
International Bowel Ultrasound Group e.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures.Patients with a previously documented Crohn's disease diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria.Age =18 years old.Examinations needed as standard of care.
Exclusion criteria
Exclusion criteria: Pregnancy and female patients of child-bearing potential planning a pregnancy during the study periodPatients with a primary diagnosis of ulcerative colitis or IBD unclassified or microscopic colitis Patients with disease limited to the upper GI tract, rectum or perianal CDPatients with a contraindication for MR, colonoscopy and/or ultrasoundPatients with allergy to gadolinium chelated or with eGFR<60 mL/min/1.73m2Patients unwilling or unable to provide informed, written consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between the LI-IUS scores and the LI-MRE and colonoscopy scores in assessing colon damage in patients with CD.Difference between the LI-IUS and LI-MRE segmental damage scores (terminal ileum) and LI-IUS and LI-MRE+colonoscopy (all colonic segments, except rectum).Difference between the small bowel, colon and global LI-IUS and LI-MRE scores by local investigators and central readers.Acceptability rate of IUS, MRE and colonoscopy.Difference between the evaluations of small bowel and colon LI-IUS damage scores between central readers.Difference between the evaluations of small bowel and colon LI-MRE damage scores between central readers.Difference between repeated evaluations of small bowel and colon LI-IUS damage scores by central readers.Differencen between repeated evaluations of small bowel and colon LI-MRE damage scores by central readers.Difference between IBD disability index and small bowel and colon damage scores, as evaluated by IUS or by MRE.Difference between IUS and MRE for the presence and distribution of stricturing and penetrating lesions by central readers. | — |
Countries
Belgium, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactSR Royo
International Bowel Ultrasound Group e.V.
Outcome results
None listed