The ImageKids Study: Developing the pMEDIC and the PICMI

Crohn's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881490
• Other study ID #: ImageKids
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: April 27, 2017
• Start date: January 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (26)

Lead Sponsor

Collaborator

Shaare Zedek Medical Center

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

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Exploratory	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
Secondary	Exploratory	To identify biological and clinical markers, predictive of intestinal damage.	3.5 Years

External Links

•   The ImageKids study website