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

This study is currently recruiting participants.
Verified November 2012 by Haukeland University Hospital
Sponsor:
Collaborators:
University of Bergen
Abbott
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01074580
First received: February 23, 2010
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Remission defined by Crohns disease activity index (CDAI)<150 [ Time Frame: 52 weeks from inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Mucosal biopsies from the colon and terminal ileum.


Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074580

Contacts
Contact: Kim Nylund, Cand.med. 004755973079 kim.nylund@helse-bergen.no
Contact: Trygve Hausken, PhD 004755972134 trygve.hausken@helse-bergen.no

Locations
Norway
Department of Medicine, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Kim Nylund, Cand.med.     00475597379     kim.nylund@helse-bergen.no    
Contact: Trygve Hausken, PhD     004755972134     trygve.hausken@helse-bergen.no    
Principal Investigator: Kim Nylund, Cand.med            
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Abbott
Investigators
Study Director: Trygve Hausken, PhD Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
  More Information

Additional Information:
Webpage for the National Center of Gastroenterological Ultrasonography (In norwegian only)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01074580     History of Changes
Other Study ID Numbers: 22209
Study First Received: February 23, 2010
Last Updated: November 15, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Crohn's disease
sonography
contrast enhanced ultrasound

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 21, 2013