Comparative Effectiveness of MR Enterography

NCT01593462 | Completed DMC

• 1 other identifier: HUM00046580
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately diagnosing and following Small Bowel Crohn Disease (SBCD) in children.

Conditions

Crohns Disease

Outcome Measures

Primary Outcomes (1)

• Effectiveness of MR Enterography, Enteric US, US Elastography Imaging with ARFI

  To assess accuracy in imaging techniques

  6 months

Secondary Outcomes (1)

• Cost effectiveness and patient imaging preferences

  6 months

Study Arms (1)

Pediatric Small Bowel Crohn's Disease

EXPERIMENTAL

MRE (magnetic resonance enterography) performed 4 weeks after SBCD treatment begins, or ends or treatment changes, or at 6 months whichever comes first. One research MRE will be performed and one MRE may or may not be performed as part of your routine care.

Procedure: MRE (magnetic resonance enterography); Procedure: The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse); Behavioral: Study Questionnaires

Interventions

MRE (magnetic resonance enterography) PROCEDURE

The MRE will take approximately 60 minutes to complete. Enrolled subject will have MRE imaging performed at about 4 weeks after treatment for small bowel crohn's disease begins, and when the treatment ends or changes or at 6 months, whichever comes first. The 4 week MRE will be for research purposes only, the treatment end,change or 6 month MRE may or may not be ordered by the treating physician as part of your routine care. If one is not ordered by the treating physician, the subject will have one performed because of the research study.

Pediatric Small Bowel Crohn's Disease

The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse) PROCEDURE

The US UEI will take about 60 minutes to perform. This exam will be performed by 2 different radiologists and you will have this completed 5 times over the course of the study. This imaging will be performed with the subject drinking oral contrast material. The US, UEI will be completed at baseline, 2 weeks, 4 weeks, 3 months and at treatment end/change or 6 months, whichever comes first.

Pediatric Small Bowel Crohn's Disease

Study Questionnaires BEHAVIORAL

The subject and their parent will be asked to answer questionnaires 2 weeks after the first MRE and US exams and again after the last imaging examinations are performed at treatment end/change or 6 months, whichever comes first. A Pediatric Crohn Disease Activity Index Assessment will be performed at baseline, 2 weeks, 4 weeks, 3 months, and at treatment end/change or 6 months, whichever comes first. The study questionnaires should take no longer than 10 to 40 minutes to complete.

Pediatric Small Bowel Crohn's Disease

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients under 18 years age.
• Recently diagnosed with small bowel crohn's disease and have not received any prior treatment for this condition

You may not qualify if:

• Are pregnant.
• Require sedation to have the MRE exam.
• Cannot tolerate small enclosed spaces for 60 minutes.
• Have kidneys that are poorly functioning (eGFR \<30ml/min)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Steien DB, Dillman JR, Lopez MJ, Ehrlich P, Adler J. Morphometric Changes in Children With Small Bowel Crohn Disease During Induction of Therapy: A Pilot Study. J Pediatr Gastroenterol Nutr. 2021 Apr 1;72(4):603-609. doi: 10.1097/MPG.0000000000003009.

  PMID: 33264183 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Dillman, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

• Jonathan Dillman, M.D.

  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: April 26, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)