Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-26 @ 9:18 PM
Study NCT ID:
NCT07234604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 1', 'timeFrame': 'Immediately after surgery', 'description': 'Accuracy between predicted bronchovascular anatomy by 3D CT and 2D CT reconstruction compared to intraoperative observations'}, {'measure': 'RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 2', 'timeFrame': 'Immediately after surgery', 'description': 'Accuracy between predicted tumor location by 3D CT and 2D CT reconstruction compared to intraoperative observations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Segmentectomy', '3D reconstruction', 'Computed tomography', 'Minimally invasive surgery'], 'conditions': ['Lung Cancer', 'Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To assess the RELIABILITY in terms of accuracy of 3D-CT and 2D-CT reconstructions compared to intraoperative data regarding bronchovascular anatomy and tumor location. 3D CT reconstruction (CT scan without contrast injection) with Innersight3D® is equivalent to 2D CT (CT scan with contrast injection) for planning a minimally invasive lung segmentectomy.\n\nEvaluate the impact of 3D reconstruction (from a CT scan without injection of contrast agent) on intraoperative and postoperative results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Adult patient ≥ 18 years\n* with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.\n* Chest CT scan available without and then with contrast\n* Eligible for VATS or RATS segmentectomy based on respiratory explorations', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patient ≥ 18 years\n* Patient agreeing to participate in the study\n* Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.\n* Chest CT scan available without and then with contrast\n* Eligible for VATS or RATS segmentectomy based on respiratory explorations\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Allergic reactions to radiographic contrast agents\n* History of ipsilateral cardiothoracic surgery\n* Open segmentectomy (thoracotomy)\n* Histology different from that of NSCLC\n* Inability to provide the subject with informed information (difficulty understanding the subject, insufficient command of French, etc.)\n* Pregnant or breastfeeding women\n* Severe cognitive impairment and/or suspicion of lack of compliance or adherence, in the investigator's judgment"}, 'identificationModule': {'nctId': 'NCT07234604', 'acronym': '3D-LS', 'briefTitle': 'Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?', 'orgStudyIdInfo': {'id': '9776'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical stage IA lung lesions & malignancy', 'description': 'Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy, cf eligibility criteria', 'interventionNames': ['Diagnostic Test: Thoraco-abdomino-pelvic CT scan without and with contrast injection.']}], 'interventions': [{'name': 'Thoraco-abdomino-pelvic CT scan without and with contrast injection.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Eligible patients undergo the usual preoperative procedure, including consultations and CT scan with and without contrast injection.', 'armGroupLabels': ['Clinical stage IA lung lesions & malignancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Pierre-Emmanuel FALCOZ, MD, PhD', 'role': 'CONTACT', 'email': 'pierre-emmanuel.falcoz@chru-strasbourg.fr', 'phone': '33 3 69 55 08 54'}, {'name': 'Chloé MOINET, Interne', 'role': 'CONTACT', 'email': 'chloe.moinet@chru-strasbourg.fr', 'phone': '33 3 69 55 08 54'}, {'name': 'Pierre-Emmanuel FALCOZ, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alex FOURDRAIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaniss BELAROUSSI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chloé MOINET, Resident doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Chirurgie Thoracique - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Pierre-Emmanuel FALCOZ, MD, PhD', 'role': 'CONTACT', 'email': 'pierre-emmanuel.falcoz@chru-strasbourg.fr', 'phone': '33 3 69 55 08 54'}, {'name': 'Chloé Moinet, Resident doctor', 'role': 'CONTACT', 'email': 'chloe.moinet@chru-strasbourg.fr', 'phone': '33 3 69 55 08 54'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}