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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rune Wilkens, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01365767
First received: May 27, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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
Crohn Disease

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Regionshospitalet Silkeborg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Crohn Disease
Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated on Regional Hospital of Silkeborg.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365767

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

No publications provided

Responsible Party: Rune Wilkens, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT01365767     History of Changes
Other Study ID Numbers: HGRWLBKULT1, 2010-024528-12
Study First Received: May 27, 2011
Last Updated: July 15, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Regionshospitalet Silkeborg:
Crohn disease
Ultrasonography, contrast enhanced
Elasticity Imaging Techniques
Small intestine
Magnetic Resonance Imaging
CDAI
Calprotectin
IBD
Sonography

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

ClinicalTrials.gov processed this record on September 30, 2014