Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease (KULT)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||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)|
- Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging [ Time Frame: up to 1 week ] [ Designated as safety issue: Yes ]Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel
- Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
- Correlation between Doppler Score and Contrast Enhanced Ultrasound Score [ Time Frame: up to 1 week ] [ Designated as safety issue: Yes ]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 [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
- Correlation between Ultrasound score and Faeces Calprotectin [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
- Correlation between Crohns disease activity index and Ultrasound score [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365767
|Aarhus University Hospital|
|Aarhus, Denmark, DK-8000|
|Medical department, Regional Hospital of Silkeborg|
|Silkeborg, Denmark, DK-8600|
|Study Chair:||Henning Glerup||Region Hospital of Silkeborg|
|Principal Investigator:||Rune Wilkens||Region Hospital of Silkeborg|
|Principal Investigator:||Lars B. Hansen||Aarhus University Hospital|