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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024528-12 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn Disease | Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated on Regional Hospital of Silkeborg.
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| Name | Affiliation | Role |
|---|---|---|
| Henning Glerup | Region Hospital of Silkeborg | Study Chair |
| Rune Wilkens | Region Hospital of Silkeborg | Principal Investigator |
| Lars B. Hansen | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | DK-8000 | Denmark | |||
| Medical department, Regional Hospital of Silkeborg |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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 |
| Silkeborg |
| DK-8600 |
| Denmark |
| D007410 | Intestinal Diseases |