Developing the Pediatric MR Enterography-based Damage Index in Crohn's disease (pMEDIC) and the Pediatric Inflammatory Crohn's MRE Index (PICMI)

Completed

Conditions: Crohn's disease
inflammatory bowel disease
10017969

Registration Number: NL-OMON40392

Lead Sponsor: Shaare Zedek Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- Children from age 5 (under 18 years of age) with established diagnosis of Crohn's disease involving any location, by the presence of accepted clinical, radiologic, endoscopic and histological criteria
- enrolment at the time of performing ileocolonoscopy and esophageal-gastroduodenoscopy (EGD) as part of clinical care for any reason
- Children will be enrolled at any phase of the disease (at diagnosis and thereafter as required clinically). In order to ensure enough subjects with intestinal damage and since damage is progressing over time, enrolment will be stratified based on disease duration. Enrolment for each stratum of disease duration will be closed after reaching the expected sample size
* 20% of enrolment children will be within 3 months of diagnosis
* 20% of children will be between 3 months and 2 years
* 20% will be 2 to 3 years
* 40% will have disease duration over 3 years
- Children may be enrolled in any disease activity state, Pediatric Crohn's Disease Activity Index (PCDAI) between 0 and 100.

Exclusion Criteria

- Young children requiring anesthesia for the MRE because of lack of cooperation will be excluded (since the enteric contrast cannot be administered during the 2 hours before anesthesia and it is crucial that the contrast be given just prior the test)
- For the first 120 children only, subjects who are not expected to be available for 18 months follow-up, will be excluded (the last 120 subjects may be enrolled as they are not followed longitudinally)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To develop an MRI-based index for assessment of intestinal damage in<br /><br>pediatric Crohn's disease (pMEDIC) , using robust psychometric and clinimetric<br /><br>methods<br /><br>2. To develop an MRI-based index of radiologist reported signs of bowel<br /><br>inflammation/bowel inflammation in pediatric Crohn's disease (PICMI), using<br /><br>robust psychometric and clinimetric methods<br /><br>3. To evaluate both indices for their clinimetric properties, including<br /><br>reliability, validity and responsiveness</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To descibe the 18-month progression rate of intestinal damage in pediatric<br /><br>Crohn's disease, stratified by the different medications used, and disease<br /><br>duration at enrolment<br /><br>2. To identify biological and clinical markers, predictive of intestinal damage</p><br>