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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01671579
• Other study ID #: HUM00061688
• Status: Terminated
• Phase: N/A
• First received: August 20, 2012
• Last updated: January 23, 2018
• Start date: March 2012
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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