Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease

Crohn Disease Clinical Trial

— KULT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365767
• Other study ID #: HGRWLBKULT1
• Secondary ID: 2010-024528-12
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: July 15, 2013
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: July 2013
• Source: Regionshospitalet Silkeborg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Crohn Disease

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Medical department, Regional Hospital of Silkeborg	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Rune Wilkens

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging	Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel	up to 1 week	Yes
Secondary	Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel		up to 1 week	No
Secondary	Correlation between Doppler Score and Contrast Enhanced Ultrasound Score	Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure	up to 1 week	Yes
Secondary	Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging		up to 1 week	No
Secondary	Correlation between Ultrasound score and Faeces Calprotectin		up to 2 months	No
Secondary	Correlation between Crohns disease activity index and Ultrasound score		up to 2 months	No