Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT02747095
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2016-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 980}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-30', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of improvement in specificity (measures the proportion of negatives that are correctly identified) of spectral coronary CTA for detection of coronary stenoses in need of treatment over conventional coronary CTA', 'timeFrame': 'One Year'}], 'secondaryOutcomes': [{'measure': 'Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.', 'timeFrame': 'One Year'}, {'measure': 'Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.', 'timeFrame': 'One Year'}, {'measure': 'Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components', 'timeFrame': 'One Year'}, {'measure': 'Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components', 'timeFrame': 'One Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CT', 'Spectral Images'], 'conditions': ['Artery', 'Deformity', 'Coronary (Acquired)']}, 'descriptionModule': {'briefSummary': 'The CT examination on IQon Spectral CT would be a standard of care CT performed as per the clinical indication. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced. And therefore, the primary study aim is to assess the impact of IQon Spectral CT scanner and applications on the clinical workflow of the site as well as the diagnostic confidence levels of the physicians reading the CT cases.\n\nIn addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning protocols, optimization of reconstruction parameters; evaluate the utility of iodine maps and other supported materials.', 'detailedDescription': 'The study aim is to assess the added diagnostic value and impact on workflow of Philips IQon Spectral Computed Tomography.\n\nThe IQon Spectral CT generates two result types:\n\n* Conventional CT images which are equivalent to images produced by the commercially available Brilliance iCT scanner\n* Spectral CT images which are unique to this product.\n\nThe CT examination would be a standard of care CT performed as per the clinical indication.\n\nIn addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning parameters, optimization of reconstruction parameters to utilize the capabilities of the IQon system etc.\n\nThe clinical system includes:\n\n* The IQon Spectral CT scanner\n* Spectral Diagnostic suite (Philips IntelliSpace Portal): includes 5 applications. Spectral Enhanced CT Viewer, Spectral Enhanced Advanced Analysis, Spectral Enhanced Comprehensive Cardiac Analysis, Spectral Enhanced Tumor Tracking, spectral magic glass on PACS.\n\nThe testing will be conducted under this project plan. This is a single center research study that is expected to be conducted over a one year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects clinically indicated to have a CT scan as part of their routine, standard medical care. Subjects must be capable of providing informed consent for the retrospective use and analysis of the IQon Spectral CT data for the research study.\n\nExclusion Criteria:\n\n* Subjects that are not clinically indicated to have a CT scan as part of their routine, standard medical care. Subjects that are not capable of providing informed consent for the retrospective use and analysis of the IQon Spectral CT data for the research study.'}, 'identificationModule': {'nctId': 'NCT02747095', 'briefTitle': 'Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Healthcare'}, 'officialTitle': 'Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)', 'orgStudyIdInfo': {'id': 'DHF246925'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spectral CT image', 'description': 'Interventions: IQon Spectral CT', 'interventionNames': ['Device: IQon Spectral CT']}], 'interventions': [{'name': 'IQon Spectral CT', 'type': 'DEVICE', 'description': 'Using IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images', 'armGroupLabels': ['Spectral CT image']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht Medical Center', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Tim Leiner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utrect Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UMC Utrecht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}