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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024528-12-DK

Enrollment

Registered

2011-01-24

Start date

2011-02-14

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbus Crohn disease with signs of activity in the small bowel. MedDRA version: 12.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Interventions

Trade Name: SonoVue Pharmaceutical Form: Powder for solution for injection CAS Number: 2551-62-4 Other descriptive name: SULFUR HEXAFLUORIDE Concentration unit: µg/ml microgram(s)/millilitre Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. To compare Ultrasound doppler score and CEUS score To compare bowel wall thickness meassured by Ultrasound and MRI with disease activity. To find a correlation between disease activity measured by Ultrasound and MRI To compare Ultrasound score with faeces Calprotectin 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.	—

Measure

Time frame

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. To compare Ultrasound doppler score and CEUS score To compare bowel wall thickness meassured by Ultrasound and MRI with disease activity. To find a correlation between disease activity measured by Ultrasound and MRI To compare Ultrasound score with faeces Calprotectin 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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026