Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST)

Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) - CONTRAST

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005886-19-DK

Enrollment

Registered

2012-07-31

Start date

2012-07-31

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

Crohns Disease with active disease MedDRA version: 14.1 Level: PT Classification code 10059696 Term: Scan with contrast System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10045434 T

Interventions

Trade Name: SonoVue Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: sulphur hexafluoride CAS Number: 2551-62-4 Other descriptive name: SULFUR HEXAFLUORIDE Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Crohns disease in moderate to severe activity. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: Female subjects who are pregnant or breastfeeding. Contraindications for MRI with Dotarem Contraindications for Sonovue Inflammation not detectable by MRI and US.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare Contrast Enhanced UltraSound (CEUS) and MRI for evaluation of bowel wall perfusion in CD. ;Secondary Objective: To evaluate which of the obtained Time-intensity-Curve-parameters that correlates best with clinical and biochemical parameters.;Primary end point(s): Time-intensity-curve parameters obtained by MRI and Contrast Enhanced Ultra Sound of the thickened intestine in CD;Timepoint(s) of evaluation of this end point: At time of MRI and Contrast Enhanced Ultra Sound, no more than 1 week apart from each other.	—

Measure

Time frame

Main Objective: To compare Contrast Enhanced UltraSound (CEUS) and MRI for evaluation of bowel wall perfusion in CD. ;Secondary Objective: To evaluate which of the obtained Time-intensity-Curve-parameters that correlates best with clinical and biochemical parameters.;Primary end point(s): Time-intensity-curve parameters obtained by MRI and Contrast Enhanced Ultra Sound of the thickened intestine in CD;Timepoint(s) of evaluation of this end point: At time of MRI and Contrast Enhanced Ultra Sound, no more than 1 week apart from each other.

—

Secondary

Measure	Time frame
Secondary end point(s): MRI and Ultrasound disease specific parameters like intestinal wallthickness, wall pattern, Late enhancement, motility measurements, extraintestinal manifestations, preinflammatory dilatation;Timepoint(s) of evaluation of this end point: At time of MRI and Contrast Enhanced Ultra Sound, no more than 1 week apart from each other.	—

Countries

Denmark

Contacts

Public ContactHenning Glerup

Regionshospitalet Silkeborg

runwil@rm.dk004578417507

Outcome results

None listed

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