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

NCT ID: NCT01671579

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-08-31

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pediatric small bowel Crohn disease

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

Group Type: OTHER

Bowel ultrasound

Intervention Type: 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.

magnetic resonance enterography (MRE)

Intervention Type: 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.

Interventions

Bowel ultrasound

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

magnetic resonance enterography (MRE)

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.

Intervention Type: PROCEDURE

Other Intervention Names

abdominal ultrasound imaging; ultrasound elasticity imaging

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Dillman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan R. Dillman

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00061688

Identifier Type: -

Identifier Source: org_study_id