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The ImageKids Study: Developing the pMEDIC and the PICMI

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ClinicalTrials.gov Identifier: NCT01881490
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : May 1, 2017
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
McMaster Children's Hospital
IWK Health Centre
Alberta Children
The Hospital for Sick Children
Children's Hospital of Philadelphia
Connecticut Children's Medical Center
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Hasbro Children's Hospital
C.S. Mott Children's Hospital
Hospital Sant Joan de Deu
Hospital Materno-Infantil de Málaga
Hôpital Necker-Enfants Malades
Erasmus Medical Center
Leiden University Medical Center
Yorkhill Hospital
Dr. von Hauner Children’s Hospital
Klinikum Stuttgart
Royal Children's Hospital
Sydney Children's Hospitals Network
Sheba Medical Center
Soroka University Medical Center
Rambam Health Care Campus
Schneider Children
Information provided by (Responsible Party):
Dr Dan Turner, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Device: MRE Not Applicable

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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. Exploratory [ Time Frame: 3.5 Years ]
    To identify biological and clinical markers, predictive of intestinal damage.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881490


Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Children's Hospital of Eastern Ontario
McMaster Children's Hospital
IWK Health Centre
Alberta Children
The Hospital for Sick Children
Children's Hospital of Philadelphia
Connecticut Children's Medical Center
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Hasbro Children's Hospital
C.S. Mott Children's Hospital
Hospital Sant Joan de Deu
Hospital Materno-Infantil de Málaga
Hôpital Necker-Enfants Malades
Erasmus Medical Center
Leiden University Medical Center
Yorkhill Hospital
Dr. von Hauner Children’s Hospital
Klinikum Stuttgart
Royal Children's Hospital
Sydney Children's Hospitals Network
Sheba Medical Center
Soroka University Medical Center
Rambam Health Care Campus
Schneider Children
Investigators
Principal Investigator: Dan Turner Shaare Zedek Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Dan Turner, Head of Pediatric Gastroenterology Unit, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01881490     History of Changes
Other Study ID Numbers: ImageKids
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Dr Dan Turner, Shaare Zedek Medical Center:
Crohn's Disease
MRE
Pelvic MRI
P-MRI
colonoscopy
gastroscopy

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases