Viewing Study NCT01059032


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Study NCT ID: NCT01059032
Status: COMPLETED
Last Update Posted: 2015-06-02
First Post: 2010-01-21
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Enhancement and Restoring of Low Dose Abdominal CT Images
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2010-01-21', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rating of image quality', 'timeFrame': '3-6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Radiation Protection']}, 'descriptionModule': {'briefSummary': 'Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast.\n\nExclusion Criteria:\n\n* Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast'}, 'identificationModule': {'nctId': 'NCT01059032', 'briefTitle': 'Enhancement and Restoring of Low Dose Abdominal CT Images', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Enhancement and Restoring of Low Dose Abdominal CT Images by a Novel Adaptive Nonlinear 3D Post Processing Filter - a Prospective Blinded Interventional Study', 'orgStudyIdInfo': {'id': '15017044793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Unenhanced images'}, {'type': 'OTHER', 'label': 'Enhanced images', 'description': 'Enhanced images', 'interventionNames': ['Other: Using a 3 dimentional post processing filter']}], 'interventions': [{'name': 'Using a 3 dimentional post processing filter', 'type': 'OTHER', 'description': 'Using a 3 dimentional post processing filter', 'armGroupLabels': ['Enhanced images']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3014', 'city': 'Drammen', 'country': 'Norway', 'facility': 'Buskerud Hospital', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Borgen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset Buskerud HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lars Borgen', 'investigatorAffiliation': 'University of Oslo'}}}}