The ImageKids Study: Developing the pMEDIC and the PICMI

April 27, 2017 updated by: Dr Dan Turner, Shaare Zedek Medical Center

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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
Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)
Other Names:
  • MRI
  • Pelvic MRI
Active Comparator: Group 2
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
Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)
Other Names:
  • MRI
  • Pelvic MRI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory
Time Frame: 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.
3.5 years
Exploratory
Time Frame: 3.5 Years
To identify biological and clinical markers, predictive of intestinal damage.
3.5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Collaborators

The Hospital for Sick Children
Rambam Health Care Campus
Children's Hospital of Philadelphia
Erasmus Medical Center
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Sheba Medical Center
Children's Hospital of Eastern Ontario
Hasbro Children's Hospital
Sydney Children's Hospitals Network
Royal Children's Hospital
IWK Health Centre
McMaster Children's Hospital
Leiden University Medical Center
C.S. Mott Children's Hospital
Soroka University Medical Center
Connecticut Children's Medical Center
Hôpital Necker-Enfants Malades
Dr. von Hauner Children's Hospital
Hospital Sant Joan de Deu
Klinikum Stuttgart
Alberta Children
Hospital Materno-Infantil de Málaga
Yorkhill Hospital
Schneider Children

Investigators

  • Principal Investigator: Dan Turner, Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 16, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImageKids

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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