Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT

Phase 1

• Conditions: Morbus Crohn disease with signs of activity in the small bowel.; MedDRA version: 12.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2010-024528-12-DK
• Lead Sponsor: Henning Glerup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-24
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Age >= 18
Reffered to dynamic MRI scan of the small bowel
Negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy
livertransplantated
allergi for contrast agents
Contraindications for contrast MRI scans
Recent myocardial infarction
Recent coronary angiography
Recent significant ECG changes
Often angina pectoris within the last week
heart failure
Serious heart arrhythmia
Serious and uncontrolled hypertension
Adult respiratory distress syndrome
Serious elevated arterial blood pressure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare Ultrasound and MRI contrast time intensity curves on inflamed parts of the small bowel at morbus crohn patients;Secondary Objective: To compare Ultrasound and MRI elastography histiograms.<br>To compare Ultrasound doppler score and CEUS score<br>To compare bowel wall thickness meassured by Ultrasound and MRI with disease activity.<br>To find a correlation between disease activity measured by Ultrasound and MRI<br>To compare Ultrasound score with faeces Calprotectin<br>To compare Ultrasound score with Crohns Disease Activity Index.;Primary end point(s): In morbus Crohn patients, is inflammation in the small bowel and colon detectable by Ultrasound and are the findings comparable with MRI findings.