The ImageKids Study: Developing the pMEDIC and the PICMI

Study Overview
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Brief Summary
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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
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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.

Official Title
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The ImageKids Study: Developing the Pediatric MR Enterography-based Damage Index in Crohn's Disease (pMEDIC) and the Pediatric Inflammatory Crohn's MRE Index (PICMI)

Conditions
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Crohn's Disease

Intervention / Treatment
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* Device: MRE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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 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. Children may be enrolled in any disease activity state (PCDAI 0-100). Exclusion Criteria: 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). 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).

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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. | Device: MRE<br>* Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)<br>* Other names: Pelvic MRI;|
| Active Comparator: Group 2<br>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. | Device: MRE<br>* Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)<br>* Other names: Pelvic MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of MRI-based Index | 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. | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory | To describe the 18-month progression rate of intestinal damage in pediatric Crohn's disease, stratified by the different medications used, and disease duration at enrolment. | 3.5 years | 
| Exploratory | To identify biological and clinical markers, predictive of intestinal damage. | 3.5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, MRE, Pelvic MRI, P-MRI, colonoscopy, gastroscopy