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

Rune Wilkens

Status: Completed

Conditions: Crohn Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01365767

2010-024528-12 (EudraCT Number)

HGRWLBKULT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Crohn Disease

Description:

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