Combined Dynamic MR enterography and colonography in pediatric patients with suspected IBD

• Conditions: Crohn's disease; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON34999
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Clinically suspected inflammatory bowel disease
Scheduled to undergo endoscopy
Scheduled to undergo MRI
Written Informed patients (>12 years of age) and parental consent

Exclusion Criteria

Age < 8 and > 18 years
General contraindications for MRI (such as pregnancy, claustrophobia, renal insufficiency) or endoscopy
Lack of written informed consent
Inability to perform a 20 second breath hold
Inability to drink 800 ml of the oral contrast agent (Sorbitol).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the accuracy of diagnosing CD or UC with<br /><br>dynamic contrast enhanced MR enterography and colonography as compared to upper<br /><br>and lower tract endoscopy and abdominal ultrasound. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters will be the comparison of DCE-MRI with<br /><br>histopathological biopsies and Pedriatric Crohn*s Disease Activity Index en<br /><br>Pediatric Ulcerative Colitis Activity Index scores for grading disease activity<br /><br>in IBD patients.</p><br>