Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:12 AM
Study NCT ID:
NCT07317466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Image for Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale', 'timeFrame': 'Reading session at 4 months', 'description': 'The image quality and diagnostic confidence of Precise Image reconstructions is non-inferior to iDose4 reconstructions for head and body CT images of pediatric patients (from 18 months up to and including 18 years of age). Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Precise Image', 'CT5300', 'Incisive CT'], 'conditions': ['Computed Tomography']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm in pediatric patients (specifically, head and body CT imaging of patients from 18 months up to and including 18 years of age). Clinical data generated from this study is intended to support a proposed expansion of the intended population of Precise Image.\n\nThe study has two objectives:\n\n1. To evaluate the image quality and diagnostic confidence of Precise Image compared to the standard-of-care reference (iDose4) for:\n\n * Head and body CT images of pediatric patients (from 18 months up to and including 18 years of age).\n2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant anatomy and resolution groups.', 'detailedDescription': 'This is a retrospective, observational, multi-site, controlled, blinded, non-inferiority clinical investigation.\n\nPrecise Image is a reconstruction mode using a trained deep learning neural network to generate images with reduced noise and improved low contrast detectability at lower doses compared with standard FBP (filter back projection) reconstruction.\n\nPediatric subjects (from 18 months up to and including 18 years of age) scanned by the FDA-cleared Philips Incisive CT (K212441) or CT 5300 (K232491) systems.\n\nThe study will include reconstructed images of 168 CT scans in total. For each of the anatomies and resolutions, 42 scans will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '18 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatrics', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.\n* Subject age: From 18 months up to and including 18 years of age.\n\nExclusion Criteria:\n\n* Subject age: Below 18 months and above 18 years of age.\n* Scans that were acquired using generic 'Head' and 'Body' scan types (as Precise Image does not support generic 'Head' and 'Body' scan types).\n* Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).\n* Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).\n* Scans that are not completed due to technical difficulties."}, 'identificationModule': {'nctId': 'NCT07317466', 'briefTitle': 'Precise Image for Pediatrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Clinical Study for Precise Image for Pediatrics for Incisive CT and CT 5300 Systems', 'orgStudyIdInfo': {'id': 'Precise Image for Pediatrics'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Philips Healthcare (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}