Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease
Primary Purpose
Crohn Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bowel ultrasound
magnetic resonance enterography (MRE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or younger
- Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.
Exclusion Criteria:
- Subjects with suspected or newly diagnosed Crohn disease
Subject who have the following in their body may not undergo MRE imaging:
- Metal chips/shrapnel
- Surgical clips
- Artificial joints
- Metallic bone plates
- Prosthetic devices
- Heart pacemakers
- Clips in or around the eye balls
- artificial heart valves
- Bullet fragments
- Chemotherapy or insulin pumps
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pediatric small bowel Crohn disease
Arm Description
Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
Outcomes
Primary Outcome Measures
Follow-up of known small bowel Crohn disease
A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT01671579
First Posted
August 20, 2012
Last Updated
January 23, 2018
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01671579
Brief Title
Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease
Official Title
Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
PI changed institutions
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard.
Detailed Description
25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pediatric small bowel Crohn disease
Arm Type
Other
Arm Description
Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
Intervention Type
Procedure
Intervention Name(s)
Bowel ultrasound
Other Intervention Name(s)
abdominal ultrasound imaging, ultrasound elasticity imaging
Intervention Description
The ultrasound imaging will take place prior to the clinically ordered MRE exam. The subject will be asked to lie on the ultrasound table for approximately 60 minutes while a variety of ultrasound images are completed.
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance enterography (MRE)
Intervention Description
The subject will have a small intravenous (IV) catheter placed in on of their arms before the MRE exam. Medications called Glucagon and MultiHance will be given thru the IV catheter during the imaging study. The glucagon will decrease the movement of the intestines, which helps provide better images of the bowel. MultiHance is a contrast that helps create clearer MRE images. In addition to the MultiHance, the subject will be given an oral contrast medication called VoLumen to drink approximately 45 minutes before the MRE imaging is started. These medications are used for all clinically necessary MRE studies performed in children and adults at the UMHS. The MRE will take approximately 50 to 60 minutes to complete.
Primary Outcome Measure Information:
Title
Follow-up of known small bowel Crohn disease
Description
A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or younger
Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.
Exclusion Criteria:
Subjects with suspected or newly diagnosed Crohn disease
Subject who have the following in their body may not undergo MRE imaging:
Metal chips/shrapnel
Surgical clips
Artificial joints
Metallic bone plates
Prosthetic devices
Heart pacemakers
Clips in or around the eye balls
artificial heart valves
Bullet fragments
Chemotherapy or insulin pumps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan R. Dillman
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease
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