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Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease (KULT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365767
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : July 16, 2013
Information provided by (Responsible Party):
Rune Wilkens, Regionshospitalet 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.

Condition or disease
Crohn Disease

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.

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Study Type : Observational
Actual Enrollment : 5 participants
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)
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Crohn Disease
Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.

Primary Outcome Measures :
  1. Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging [ 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

Secondary Outcome Measures :
  1. Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel [ Time Frame: up to 1 week ]
  2. Correlation between Doppler Score and Contrast Enhanced Ultrasound Score [ Time Frame: up to 1 week ]
    Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure

  3. Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging [ Time Frame: up to 1 week ]
  4. Correlation between Ultrasound score and Faeces Calprotectin [ Time Frame: up to 2 months ]
  5. Correlation between Crohns disease activity index and Ultrasound score [ Time Frame: up to 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated on Regional Hospital of Silkeborg.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365767

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Aarhus University Hospital
Aarhus, Denmark, DK-8000
Medical department, Regional Hospital of Silkeborg
Silkeborg, Denmark, DK-8600
Sponsors and Collaborators
Rune Wilkens
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Study Chair: Henning Glerup Region Hospital of Silkeborg
Principal Investigator: Rune Wilkens Region Hospital of Silkeborg
Principal Investigator: Lars B. Hansen Aarhus University Hospital

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Responsible Party: Rune Wilkens, MD, Regionshospitalet Silkeborg Identifier: NCT01365767     History of Changes
Other Study ID Numbers: HGRWLBKULT1
2010-024528-12 ( EudraCT Number )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by Rune Wilkens, Regionshospitalet Silkeborg:
Crohn disease
Ultrasonography, contrast enhanced
Elasticity Imaging Techniques
Small intestine
Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases