The ImageKids Study: Developing the pMEDIC and the PICMI

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Device: MRE

• Registration Number: NCT01881490
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

The overall objectives of this study are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's disease by means of Magnetic Resonance Imaging with Enterography protocol (MRE) and pelvic MRI.

Detailed Description

The PICMI Score and the pMEDIC are aimed to be discriminative (at one point in time), evaluative (measuring damage progression over time) and predictive. The indices will be used as endpoint measures in clinical research and also in clinical practice to identify those who are at risk for rapid disease progression and surgery.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-16
• Study First Posted: 2013-06-19
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Children (under 18 years of age) with established diagnosis of CD involving any location by the presence of accepted clinical, radiologic, endoscopic and histologic criteria (33, 34).

2. Enrolment at the time of performing ileocolonoscopy and esophageal-gastroduodenoscopy (EGD) as part of clinical care for any reason.

3. 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 enrolled children will be within 3 months of diagnosis.
   • 20% of children will be between 3 months and 2 years.
   • 20% will be 2.01 to 3 years
   • 40% will have disease duration over 3-years.

4. Children may be enrolled in any disease activity state (PCDAI 0-100).

Exclusion Criteria

1. Young children requiring anesthesia for 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).
2. For the first 120 children only, subjects not expected to be available for 18 month follow-up, will be excluded (the last 120 subjects may be enrolled as they are not followed longitudinally).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MRE	120 Children with Crohn's disease undergoing MRE \& colonoscopy will be enrolled and followed for 18 months. MRE exam will be repeated at 18 months.
Group 2	MRE	120 children with Crohn's disease undergoing colonoscopy will be recruited and will have an MRE/pelvic MRI performed. The two or three contending versions of each index (PICMI and pMEDIC) developed based on Group 1, will be then subjected to head-to-head evaluation of Group 2.

Primary Outcome Measures

Name	Time	Method
Development of MRI-based Index	3.5 years	The overall objectives of this study are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity means of MRE.; The indices are aimed to be discriminative, evaluative and predictive. they will be used as endpoint measures in clinical research and also in clinical practice to identify those who are at risk for rapid disease progression and surgery. The data collected will be analyzed and scored by both the radiologists and the gastroenterologists. On the basis of these scores, 2 or 3 contending versions of each index will be then subjected to head-to-head evaluation by enrolling another cohort of 120 children undergoing colonoscopy and MRE/pelvic MRI. The best version for each index will be selected according to its performance in the validity, reliability and responsiveness testing. The second group of patients will not be followed longitudinally.

Secondary Outcome Measures

Name	Time	Method
Exploratory	3.5 Years	To identify biological and clinical markers, predictive of intestinal damage.

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel