Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT01365767
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2011-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-15', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging', 'timeFrame': 'up to 1 week', 'description': 'Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel'}], 'secondaryOutcomes': [{'measure': 'Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel', 'timeFrame': 'up to 1 week'}, {'measure': 'Correlation between Doppler Score and Contrast Enhanced Ultrasound Score', 'timeFrame': 'up to 1 week', 'description': 'Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure'}, {'measure': 'Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging', 'timeFrame': 'up to 1 week'}, {'measure': 'Correlation between Ultrasound score and Faeces Calprotectin', 'timeFrame': 'up to 2 months'}, {'measure': 'Correlation between Crohns disease activity index and Ultrasound score', 'timeFrame': 'up to 2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Crohn disease', 'Ultrasonography, contrast enhanced', 'Elasticity Imaging Techniques', 'Small intestine', 'Magnetic Resonance Imaging', 'CDAI', 'Calprotectin', 'IBD', 'Sonography'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHypothesis is, that dynamic US is comparable to dynamic MRI and therefore should be the first examination of choice in evaluating patients with CD.\n\nThis study is a pilot study only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated on Regional Hospital of Silkeborg.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with known Crohns Disease\n* 18 years old or older.\n* Referred to a Magnetic Resonance Imaging scan of the small bowel\n\nExclusion Criteria:\n\n* Contraindications to or not suitable of a Magnetic Resonance Imaging\n* Liver transplant\n* nursing og pregnancy\n* Known Allergy of SonoVue\n* Acute Myocardial infarction \\< 4 weeks\n* Coronary angiography \\< 4 weeks\n* Electrocardiogram changes \\< 4 weeks\n* frequent and repetitive angina pectoris symptoms within the last week.\n* Heartfailure\n* serious arrhythmia\n* right to left heart shunt\n* Very high pulmonary artery pressure\n* uncontrolled hypertension\n* Adult respiratory distress syndrome'}, 'identificationModule': {'nctId': 'NCT01365767', 'acronym': 'KULT', 'briefTitle': 'Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Silkeborg'}, 'officialTitle': 'Kontrast UltraLydsskanning af Tyndtarmen Hos Patienter Med Crohns Sygdom - et Pilotstudie. (Danish) Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease - a Pilot Study (English)', 'orgStudyIdInfo': {'id': 'HGRWLBKULT1'}, 'secondaryIdInfos': [{'id': '2010-024528-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Crohn Disease', 'description': 'Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': 'DK-8600', 'city': 'Silkeborg', 'country': 'Denmark', 'facility': 'Medical department, Regional Hospital of Silkeborg', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}], 'overallOfficials': [{'name': 'Henning Glerup', 'role': 'STUDY_CHAIR', 'affiliation': 'Region Hospital of Silkeborg'}, {'name': 'Rune Wilkens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Hospital of Silkeborg'}, {'name': 'Lars B. Hansen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rune Wilkens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rune Wilkens', 'investigatorAffiliation': 'Regionshospitalet Silkeborg'}}}}