Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-28 @ 9:34 AM
Study NCT ID:
NCT07196995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Whole Body PET/CT Foundation Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-20', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance (benign or malignant)', 'timeFrame': 'At diagnosis time', 'description': 'Patient based bone lesion diagnostic performance (benign or malignant)'}], 'secondaryOutcomes': [{'measure': 'Diagnostic performance (primary or metastases)', 'timeFrame': 'At diagnosis time', 'description': 'Patient based bone lesion diagnostic performance (primary or metastases)'}, {'measure': 'Pathology prediction', 'timeFrame': 'At diagnosis time', 'description': 'Pathology prediction'}, {'measure': 'Gene prediction', 'timeFrame': 'At diagnosis time', 'description': 'Gene prediction'}, {'measure': 'Prognosis prediction', 'timeFrame': 'At diagnosis time', 'description': 'Prognosis prediction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Metastases']}, 'descriptionModule': {'briefSummary': 'Prospective multicenter study to validate the diagnostic performance of whole body PET/CT foundation model for bone lesion detection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'With suspicious lesion in the bone', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With suspicious lesion in the bone or with elevated serum tumor markers or patient insist\n* Over 18 years\n\nExclusion Criteria:\n\n* Active infection at or adjacent to the puncture site\n* Severe coagulation disorders that cannot be corrected\n* Random blood glucose \\> 11.1 mmol/L\n* Refuse for pathological confirmation or follow-up\n* Extremely debilitated patients or those unable to cooperate'}, 'identificationModule': {'nctId': 'NCT07196995', 'briefTitle': 'Validation of Whole Body PET/CT Foundation Model', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Prospective Multicenter Validation of Whole Body PET/CT Foundation Model for Bone Lesion Detection', 'orgStudyIdInfo': {'id': 'PET/CT MODEL 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group PET/CT', 'description': 'Whole body PET/CT foundation model'}, {'label': 'Group CT', 'description': 'Whole body CT foundation model'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhao Hui', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}