The ImageKids Study: Developing the pMEDIC and the PICMI

Shaare Zedek Medical Center

Status: Completed

Conditions: Crohn's Disease

Treatments: Device: MRE

Study type: Interventional

Funder types: Other

Identifiers

NCT01881490

ImageKids

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Device: MRE

Group 2

Active Comparator group

Description:

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.

Treatment:

Device: MRE