NCT01881490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

4.2 years

First QC Date

June 12, 2013

Last Update Submit

April 27, 2017

Conditions

Crohn's Disease

Keywords

Crohn's DiseaseMREPelvic MRIP-MRIcolonoscopygastroscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Exploratory

    3.5 years

  • Exploratory

    3.5 Years

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

ACTIVE COMPARATOR

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

Interventions

MREDEVICE

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

Also known as: MRI, Pelvic MRI
Group 1Group 2

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • % of enrolled children will be within 3 months of diagnosis.
  • % of children will be between 3 months and 2 years.
  • % will be 2.01 to 3 years
  • % will have disease duration over 3-years.
  • Children may be enrolled in any disease activity state (PCDAI 0-100).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (4)

  • 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.

    PMID: 35872072DERIVED

  • 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.

    PMID: 31136561DERIVED

  • 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.

    PMID: 30981008DERIVED

  • 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.

    PMID: 29501599DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Dan Turner

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Gastroenterology Unit

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 19, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

IL(1)