Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kontrast UltraLydsskanning af Tyndtarmen Hos Patienter Med Crohns Sygdom - et Pilotstudie. (Danish) Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease - a Pilot Study (English)

Conditions
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Crohn Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn Disease<br>Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure | up to 1 week | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn disease, Ultrasonography, contrast enhanced, Elasticity Imaging Techniques, Small intestine, Magnetic Resonance Imaging, CDAI, Calprotectin, IBD, Sonography