The ImageKids Study: Developing the pMEDIC and the PICMI

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01881490
• Date of registration: 12/06/2013
• Prospective Registration: No
• Primary sponsor: Shaare Zedek Medical Center
• Public title: The ImageKids Study: Developing the pMEDIC and the PICMI
• Scientific 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)
• Date of first enrolment: January 2013
• Target sample size: 240
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01881490
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Dan Turner
• Affiliation: Shaare Zedek Medical Center

Key inclusion & exclusion 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).



Age minimum: 5 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Device: MRE

Primary Outcome(s)

Development of MRI-based Index [Time Frame: 3.5 years]

Secondary Outcome(s)

Exploratory [Time Frame: 3.5 years]

Secondary ID(s)

ImageKids

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Leiden University Medical Center

Rambam Health Care Campus

Sydney Children's Hospitals Network

C.S. Mott Children's Hospital

McMaster Children's Hospital

Schneider Children

Yorkhill Hospital

Connecticut Children's Medical Center

Hôpital Necker-Enfants Malades

IWK Health Centre

The Hospital for Sick Children

Children's Hospital Medical Center, Cincinnati

Erasmus Medical Center

Hasbro Children's Hospital

Hospital Materno-Infantil de Málaga

Children's Hospital of Philadelphia

Dr. von Hauner Children’s Hospital

Sheba Medical Center

Royal Children's Hospital

Soroka University Medical Center

Hospital Sant Joan de Deu

Nationwide Children's Hospital

Alberta Children

Children's Hospital of Eastern Ontario

Klinikum Stuttgart