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Completed

NCT Number: NCT01365767

Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rune Wilkens

Other

Registry information

Official study 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)

Acronym: KULT

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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