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

Cincinnati Children's Hospital Medical Center

Status: Terminated

Conditions: Crohn Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01671579

HUM00061688

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Pediatric small bowel Crohn disease

Other group

Description:

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

Treatment:

Procedure: Bowel ultrasound

Procedure: magnetic resonance enterography (MRE)