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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by Haukeland University Hospital.
Recruitment status was  Recruiting
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: February 23, 2010
Last updated: August 28, 2013
Last verified: August 2013
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.

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:

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)
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


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01074580

Contact: Kim Nylund, 004755973079
Contact: Trygve Hausken, PhD 004755972134

Department of Medicine, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Kim Nylund,    00475597379   
Contact: Trygve Hausken, PhD    004755972134   
Principal Investigator: Kim Nylund,         
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Study Director: Trygve Hausken, PhD Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
  More Information

Additional Information:
No publications provided

Responsible Party: Haukeland University Hospital Identifier: NCT01074580     History of Changes
Other Study ID Numbers: 22209
Study First Received: February 23, 2010
Last Updated: August 28, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases processed this record on November 24, 2015