Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease

NCT01671579 | Terminated DMC

• 1 other identifier: HUM00061688
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Pediatric small bowel Crohn disease

OTHER

Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.

Procedure: Bowel ultrasound; Procedure: magnetic resonance enterography (MRE)

Interventions

Bowel ultrasound PROCEDURE

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.

Also known as: abdominal ultrasound imaging, ultrasound elasticity imaging

Pediatric small bowel Crohn disease

magnetic resonance enterography (MRE) PROCEDURE

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.

Pediatric small bowel Crohn disease

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age or younger
• Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jonathan R. Dillman

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)