The ImageKids Study: Developing the pMEDIC and the PICMI

Conditions

Crohn's Disease

Keywords

Crohn's Disease, MRE, Pelvic MRI, P-MRI, colonoscopy, gastroscopy

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.

Joachim Høg Mortensen, G Focht, M Sorokina Alexdóttir, Ahmad Quteineh, Martin Pehrsson et al. (12 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.467

P318 Protein FingerPrint assays reflecting neutrophil activity, mucosal damage, and tissue fibrosis are surrogate biomarkers for mucosal healing in pediatric Crohn’s disease

Joachim Høg Mortensen, Gili Focht, Martin Pehrsson, A M Griffiths, Marta Sorokina Alexdóttir et al. (11 authors)

Journal of Crohn s and Colitis2023-01-301 citations

10.1093/ecco-jcc/jjac190.0448

Development, Validation, and Evaluation of the Pediatric Inflammatory Crohn's Magnetic Resonance Enterography Index From the ImageKids Study.

Focht G, Cytter-Kuint R, Greer MC, Pratt LT, Castro DA, Church PC, Walters TD, Hyams J, Navon D, Martin de Carpi J, Ruemmele F, Russell RK, Gavish M, Griffiths AM, Turner D.

2022-07-2216 citations

10.1053/j.gastro.2022.07.048

P204 Endotrophin (PRO-C6) is associated with MRE confirmed intestinal strictures and Protein FingerPrint biomarkers of collagen degradation is associated with ulcerations in paediatric Crohn’s disease patients – results from the ImageKids study

Joachim Høg Mortensen, Gili Focht, Martin Pehrsson, Anne M. Griffiths, Marta Sorokina Alexdóttir et al. (11 authors)

Journal of Crohn s and Colitis2022-01-013 citations

10.1093/ecco-jcc/jjab232.331

Development and Validation of the Mucosal Inflammation Noninvasive Index For Pediatric Crohn's Disease.

Cozijnsen MA, Ben Shoham A, Kang B, Choe BH, Choe YH, Jongsma MME, Russell RK, Ruemmele FM, Escher JC, de Ridder L, Koletzko S, Martín-de-Carpi J, Hyams J, Walters T, Griffiths A, Turner D.

2019-04-1044 citations

10.1016/j.cgh.2019.04.012

Associations Among Mucosal and Transmural Healing and Fecal Level of Calprotectin in Children With Crohn's Disease.

Weinstein-Nakar I, Focht G, Church P, Walters TD, Abitbol G, Anupindi S, Berteloot L, Hulst JM, Ruemmele F, Lemberg DA, Leach ST, Cytter R, Greer ML, Griffiths AM, Turner D, ImageKids study group.

2018-03-0285 citations

10.1016/j.cgh.2018.01.024

Interventions

DEVICEMRE

Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

No

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Exploratory	3.5 years	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.

Countries

Israel

Outcome results

None listed