Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn’s Disease

Overview

The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.

Full Title of Study: “High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn’s Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2013

Arms, Groups and Cohorts

  • Deterioration, Crohn’s disease
    • Patients > 18 years old with a deterioration of Crohn’s disease defined by CDAI >150 and requiring treatment with systemic steroids or TNF alfa inhibitors

Clinical Trial Outcome Measures

Primary Measures

  • Remission defined by Crohns disease activity index (CDAI)<150
    • Time Frame: 52 weeks from inclusion

Secondary Measures

  • Surgical treatment for Crohn’s disease during follow up. (Surgery for perianal disease not included.)
    • Time Frame: 52 weeks
  • Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn’s disease (SES-CD)
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Deterioration of Crohn's disease – CDAI>150 – Treated with systemic steroids or TNF alfa inhibitors – Lesion found on ultrasound Exclusion Criteria:

  • Disease location not reachable with ileocolonoscopy – Pregnancy – Acute coronary disease – Unstable coronary disease – Previous allergic reaction to SonoVue or its components

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Haukeland University Hospital
  • Collaborator
    • University of Bergen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Trygve Hausken, PhD, Study Director, Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway

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