Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease

Completed

• Conditions: Crohn Disease

• Registration Number: NCT01365767
• Lead Sponsor: Rune Wilkens

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging	up to 1 week	Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel

Secondary Outcome Measures

Name	Time	Method
Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel	up to 1 week
Correlation between Doppler Score and Contrast Enhanced Ultrasound Score	up to 1 week	Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure
Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging	up to 1 week
Correlation between Ultrasound score and Faeces Calprotectin	up to 2 months
Correlation between Crohns disease activity index and Ultrasound score	up to 2 months

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Medical department, Regional Hospital of Silkeborg; 🇩🇰 Silkeborg, Denmark