Clinical trial NCT01365767: Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Crohn disease
Ultrasonography, contrast enhanced
Elasticity Imaging Techniques
Small intestine
Magnetic Resonance Imaging
CDAI
Calprotectin
IBD
Sonography
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated on Regional Hospital of Silkeborg.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging
timeFrame: up to 1 week
Secondary outcomes:
measure: Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel
timeFrame: up to 1 week
measure: Correlation between Doppler Score and Contrast Enhanced Ultrasound Score
timeFrame: up to 1 week
measure: Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging
timeFrame: up to 1 week
measure: Correlation between Ultrasound score and Faeces Calprotectin
timeFrame: up to 2 months
measure: Correlation between Crohns disease activity index and Ultrasound score
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Silkeborg
country: Denmark
facility: Medical department, Regional Hospital of Silkeborg
Study officials:
affiliation: Region Hospital of Silkeborg
name: Henning Glerup
role: STUDY_CHAIR
affiliation: Region Hospital of Silkeborg
name: Rune Wilkens
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Lars B. Hansen
role: PRINCIPAL_INVESTIGATOR
References: