Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease

NCT ID: NCT01365767

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-09-30

Brief Summary

The purpose of this study is to determine how relevant dynamic ultrasound scans using contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.

Detailed Description

Crohns disease (CD) is a lifelong chronic Inflammatory Bowel Disease (IBD) normally with an early debut. It requires continuous evaluation with either endoscopy, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) or Wireless Capsule Endoscopy (WCE). These methods are either expensive, invasive or with uses radiation. Therefore UltraSound (US), as a cheap, fast and well tolerated examination of the small bowel are tested against the the validated MRI examination of the small bowel. Both examinations are using intra venous (i.v.) contrast agents. Obtained results are compared to disease activity.

Hypothesis is, that dynamic US is comparable to dynamic MRI and therefore should be the first examination of choice in evaluating patients with CD.

This study is a pilot study only.

Conditions

Crohn Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Crohn Disease

Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with known Crohns Disease
• 18 years old or older.
• Referred to a Magnetic Resonance Imaging scan of the small bowel

Exclusion Criteria

• Contraindications to or not suitable of a Magnetic Resonance Imaging
• Liver transplant
• nursing og pregnancy
• Known Allergy of SonoVue
• Acute Myocardial infarction < 4 weeks
• Coronary angiography < 4 weeks
• Electrocardiogram changes < 4 weeks
• frequent and repetitive angina pectoris symptoms within the last week.
• Heartfailure
• serious arrhythmia
• right to left heart shunt
• Very high pulmonary artery pressure
• uncontrolled hypertension
• Adult respiratory distress syndrome

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rune Wilkens

OTHER

Sponsor Role: lead

Responsible Party

Rune Wilkens

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henning Glerup

Role: STUDY_CHAIR

Region Hospital of Silkeborg

Rune Wilkens

Role: PRINCIPAL_INVESTIGATOR

Region Hospital of Silkeborg

Lars B. Hansen

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Medical department, Regional Hospital of Silkeborg

Silkeborg, , Denmark

Countries

Denmark

Other Identifiers

2010-024528-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HGRWLBKULT1

Identifier Type: -

Identifier Source: org_study_id