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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Regionshospitalet Silkeborg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01365767
First received: May 27, 2011
Last updated: June 1, 2011
Last verified: May 2011

May 27, 2011
June 1, 2011
May 2011
Not Provided
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
Same as current
Complete list of historical versions of study NCT01365767 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease
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)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients treated on Regional Hospital of Silkeborg.

Crohn Disease
Not Provided
Crohn Disease
Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Rune T. Wilkens +4527202147 runwil@rm.dk
Contact: Henning Glerup +4587222360 henngler@rm.dk
Denmark
 
NCT01365767
HGRWLBKULT1, 2010-024528-12
Yes
Henning Glerup, Regionshospitalet Silkeborg
Regionshospitalet Silkeborg
Not Provided
Study Chair: Henning Glerup Region Hospital of Silkeborg
Principal Investigator: Rune Wilkens Region Hospital of Silkeborg
Principal Investigator: Lars B. Hansen Aarhus University Hospital
Regionshospitalet Silkeborg
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP