Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 7:16 PM
Study NCT ID:
NCT07108205
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Quality Study of Spectral Precise Image CT 7700
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images', 'timeFrame': '1 day', 'description': 'Primary Endpoint (Co-Primary endpoints):\n\n1\\. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to) iDose4 for conventional images.'}, {'measure': 'Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).', 'timeFrame': '1 day', 'description': 'Primary Endpoint (Co-Primary endpoints): 2. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images', 'timeFrame': '1 day', 'description': '1\\. To evaluate the difference in Image Quality (IQ) and diagnostic confidence between Spectral Precise Image reconstructions for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head) and iDose4 for conventional images.'}, {'measure': 'Evaluation of the success rate for Spectral Precise Image reconstruction', 'timeFrame': '1 day', 'description': '2\\. To evaluate the success rate (%) for Spectral Precise Image reconstructions'}, {'measure': 'Evaluation of the interobserver agreement level for the Co-Primary endpoints', 'timeFrame': '1 day', 'description': '3\\. The interobserver agreement level for the Co-Primary endpoints is more than 0.8.'}, {'measure': 'Evaluation of images artifacts visualization and preservation of important features', 'timeFrame': '1 day', 'description': '4\\. Evaluation of images artifacts visualization and preservation of important features and clinical impact on diagnostic ability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CT', 'Tomography', 'Image Quality', 'Noise reduction'], 'conditions': ['Head', 'Body', 'Cardiac']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference.', 'detailedDescription': 'Spectral Precise Image is a reconstruction technique where the system uses a trained deep learning neural network to produce an image that reduces noise while improving low contrast detectability and maintaining the appearance of traditional filtered back projection (FBP) images.\n\nSpectral Precise Image in Spectral CT 7700 system supports both conventional and spectral reconstructions.\n\nThe study will use raw data of subjects that are over the age of 22 years and scanned by Philips Spectral CT.\n\nStudy raw data, following anonymization, will be transferred to Philips for reconstructions, both conventional and spectral images will be reconstructed with iDose4 and with Spectral Precise Image at 100% dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data from subjects that met ALL of the inclusion criteria and NONE of the exclusion criteria will be included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols.\n\n * Subjects age \\> twenty-two (22) years\n\nExclusion Criteria:\n\n* • Scans that the site radiologists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement)\n\n * Scans that are not completed due to technical difficulties'}, 'identificationModule': {'nctId': 'NCT07108205', 'briefTitle': 'Image Quality Study of Spectral Precise Image CT 7700', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Clinical Study for Spectral Precise Image (SPI) Algorithm', 'orgStudyIdInfo': {'id': 'PD-300450'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Raw data will be reconstructed with iDose4', 'description': 'Raw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with iDose4', 'interventionNames': ['Device: Paired reading analysis']}, {'label': 'Raw data will be reconstructed with Spectral Precise Image', 'description': 'Raw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with Spectral Precise Image', 'interventionNames': ['Device: Paired reading analysis']}], 'interventions': [{'name': 'Paired reading analysis', 'type': 'DEVICE', 'description': 'Paired side be side evaluation Each reader will assess- Image Quality (IQ) \\& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale', 'armGroupLabels': ['Raw data will be reconstructed with Spectral Precise Image', 'Raw data will be reconstructed with iDose4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Einstein', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}