Clinical trial NCT01881490: The ImageKids Study: Developing the pMEDIC and the PICMI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's Disease
MRE
Pelvic MRI
P-MRI
colonoscopy
gastroscopy
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Eastern Ontario
name: McMaster Children's Hospital
name: IWK Health Centre
name: Alberta Children
name: The Hospital for Sick Children
name: Children's Hospital of Philadelphia
name: Connecticut Children's Medical Center
name: Nationwide Children's Hospital
name: Children's Hospital Medical Center, Cincinnati
name: Hasbro Children's Hospital
name: C.S. Mott Children's Hospital
name: Hospital Sant Joan de Deu
name: Hospital Materno-Infantil de Málaga
name: Hôpital Necker-Enfants Malades
name: Erasmus Medical Center
name: Leiden University Medical Center
name: Yorkhill Hospital
name: Dr. von Hauner Children's Hospital
name: Klinikum Stuttgart
name: Royal Children's Hospital
name: Sydney Children's Hospitals Network
name: Sheba Medical Center
name: Soroka University Medical Center
name: Rambam Health Care Campus
name: Schneider Children
First posted: 2013-06-19
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Development of MRI-based Index
timeFrame: 3.5 years
Secondary outcomes:
measure: Exploratory
timeFrame: 3.5 years
measure: Exploratory
timeFrame: 3.5 Years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Dan Turner
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Development, Validation, and Evaluation of the Pediatric Inflammatory Crohn's Magnetic Resonance Enterography Index From the ImageKids Study. Gastroenterology. 2022 Nov;163(5):1306-1320. doi: 10.1053/j.gastro.2022.07.048. Epub 2022 Jul 22.
citation: Weiss B, Turner D, Griffiths A, Walters T, Herman-Sucharska I, Coppenrath E, Anupindi SA, Towbin AJ, O'Brien K, Silverstein J, Navas V, Koletzko S, Sladek M, Gavish M, Amitai MM; ImageKids study group. NCT01881490. Simple Endoscopic Score of Crohn Disease and Magnetic Resonance Enterography in Children: Report From ImageKids Study. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):461-465. doi: 10.1097/MPG.0000000000002404.
citation: Cozijnsen MA, Ben Shoham A, Kang B, Choe BH, Choe YH, Jongsma MME, Russell RK, Ruemmele FM, Escher JC, de Ridder L, Koletzko S, Martin-de-Carpi J, Hyams J, Walters T, Griffiths A, Turner D. Development and Validation of the Mucosal Inflammation Noninvasive Index For Pediatric Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):133-140.e1. doi: 10.1016/j.cgh.2019.04.012. Epub 2019 Apr 10.
citation: 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. Associations Among Mucosal and Transmural Healing and Fecal Level of Calprotectin in Children With Crohn's Disease. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1089-1097.e4. doi: 10.1016/j.cgh.2018.01.024. Epub 2018 Mar 2.