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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 August 2021 |
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Main ID: |
EUCTR2011-005886-19-DK |
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Date of registration:
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31/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST)
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Scientific title:
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Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) - CONTRAST |
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Date of first enrolment:
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31/07/2012 |
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Target sample size:
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25 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005886-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Henning Glerup
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Address:
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Falkevej 1-3
8600
Silkeborg
Denmark |
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Telephone:
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004578417507 |
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Email:
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runwil@rm.dk |
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Affiliation:
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Regionshospitalet Silkeborg |
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Name:
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Henning Glerup
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Address:
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Falkevej 1-3
8600
Silkeborg
Denmark |
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Telephone:
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004578417507 |
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Email:
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runwil@rm.dk |
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Affiliation:
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Regionshospitalet Silkeborg |
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Key inclusion & exclusion criteria
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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:
Female subjects who are pregnant or breastfeeding.
Contraindications for MRI with Dotarem
Contraindications for Sonovue
Inflammation not detectable by MRI and US.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
Term: Ultrasound scan
System Organ Class: 10022891 - Investigations
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Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
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Intervention(s)
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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 unit: µl/ml microlitre(s)/millilitre
Concentration type: equal
Concentration number: 8-
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Primary Outcome(s)
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Main Objective: To compare Contrast Enhanced UltraSound (CEUS) and MRI for evaluation of bowel wall perfusion in CD.
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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.
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Primary end point(s): Time-intensity-curve parameters obtained by MRI and Contrast Enhanced Ultra Sound of the thickened intestine in CD
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Secondary Objective: To evaluate which of the obtained Time-intensity-Curve-parameters that correlates best with clinical and biochemical parameters.
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Secondary Outcome(s)
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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.
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Secondary end point(s): MRI and Ultrasound disease specific parameters like intestinal wallthickness, wall pattern, Late enhancement, motility measurements, extraintestinal manifestations, preinflammatory dilatation
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Secondary ID(s)
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HGKKRWPHD2
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Source(s) of Monetary Support
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Abbott Denmark
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Ethics review
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Status: Approved
Approval date: 20/07/2012
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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