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

January 25, 2016 updated by: Haukeland University Hospital

High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Department of Medicine, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

University of Bergen
Abbott

Investigators

  • Study Director: Trygve Hausken, PhD, Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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