MRI of the small bowel and colon in determining disease activity in patients with Crohn*s disease

MRI of the small bowel and colon in determining disease activity in patients with Crohn*s disease - VIGOR++

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36153

Enrollment

Registered

2012-02-01

Start date

2011-10-24

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Crohn's disease Inflammatory Bowel Disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Proven Crohn*s disease (by endoscopy or histopathology) Scheduled to undergo an ileocolonoscopy as part of their clinical follow-up Scheduled for MRI as part of their clinical follow-up

Exclusion criteria

Exclusion criteria: Under 18 years of age General contraindications to MRI (claustrophobia, pregnancy, sever renal insufficiency) and MRI intravenous contrast agent.

Design outcomes

Primary

Measure	Time frame
The main study parameter will be the sensitivity and specificity of MRI of the colon and small bowel in grading disease activity in CD patients. Also, the added value of MRI of the colon willl be compared to routine MRI of the small bowel. Colonoscopy will serve as the reference standard.	—

Secondary

Measure	Time frame
The secondary endpoints will be the comparison of the MRI findings (additional MR imaging with DWI, T1-map and dynamic imaging (DCE-MRI)), compared to the Harvey Bradshaw index and C-reactive protein (CRP) for grading disease activity in CD patients. The study will acquire these data in order to develop and assess ICT tools for objective measurement of features of Crohn*s disease such as the bowel wall thickness. For the developing of the ICT tools we will share our data with European collaborators in the framework of an EU FP7 consortium (VIGOR++).	—

Measure

Time frame

The secondary endpoints will be the comparison of the MRI findings (additional MR imaging with DWI, T1-map and dynamic imaging (DCE-MRI)), compared to the Harvey Bradshaw index and C-reactive protein (CRP) for grading disease activity in CD patients. The study will acquire these data in order to develop and assess ICT tools for objective measurement of features of Crohn*s disease such as the bowel wall thickness. For the developing of the ICT tools we will share our data with European collaborators in the framework of an EU FP7 consortium (VIGOR++).

—

Countries

Netherlands

Outcome results