Back to resultsThe ImageKids Study: Developing the pMEDIC and the PICMI
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MRE
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn's Disease focused on measuring Crohn's Disease, MRE, Pelvic MRI, P-MRI, colonoscopy, gastroscopy
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
- Children may be enrolled in any disease activity state (PCDAI 0-100).
Exclusion Criteria:
- 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).
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Exploratory
To identify biological and clinical markers, predictive of intestinal damage.
Full Information
NCT ID
NCT01881490
First Posted
June 12, 2013
Last Updated
April 27, 2017
Sponsor
Shaare Zedek Medical Center
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
1. Study Identification
Unique Protocol Identification Number
NCT01881490
Brief Title
The ImageKids Study: Developing the pMEDIC and the PICMI
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, MRE, Pelvic MRI, P-MRI, colonoscopy, gastroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MRE
Other Intervention Name(s)
MRI, Pelvic MRI
Intervention Description
Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)
Primary Outcome Measure Information:
Title
Development of MRI-based Index
Description
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.
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Exploratory
Description
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.
Time Frame
3.5 years
Title
Exploratory
Description
To identify biological and clinical markers, predictive of intestinal damage.
Time Frame
3.5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Children may be enrolled in any disease activity state (PCDAI 0-100).
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Turner
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
35872072
Citation
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.
Results Reference
derived
PubMed Identifier
31136561
Citation
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.
Results Reference
derived
PubMed Identifier
30981008
Citation
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.
Results Reference
derived
PubMed Identifier
29501599
Citation
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.
Results Reference
derived
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The ImageKids Study: Developing the pMEDIC and the PICMI
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