A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT04673357
Crohn Disease, Digestive System Diseases
Wilmington, Delaware, United States
View Trial DetailsNCT Number: NCT01365767
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.
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Notify Me18 year and older
All sexes
Observational
Aarhus University Hospital, Aarhus, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: up to 1 week
Time frame: up to 1 week
Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure
Time frame: up to 1 week
Time frame: up to 2 months
Time frame: up to 2 months
Rune Wilkens
Other
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)
Acronym: KULT
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