[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100358905":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":63,"collaborators":21,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":21,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":21,"enrollmentInfo":75,"targetDuration":21,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":47,"whyStopped":21,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Synapse 3D Lung Modelling + IC-GREEN Segmentectomy","EXPERIMENTAL","Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg\u002F10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus",[13,14],"Device: Synapse 3D Lung Modelling","Drug: IC-Green (ICG)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Synapse 3D Lung Modelling","The 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","IC-Green (ICG)","ICG will be prepared as a sterile solution (2.5 mg\u002F10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.",[9],[28],"Indocyanine Green",[30],{"name":31,"affiliation":32,"role":33},"Waël C Hanna, MDCM, MBA, FRCSC","St. Joseph's Healthcare Hamilton \u002F McMaster University","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Peter R. A. Malik, BHSc (Honours)","CONTACT","905-522-1155","35096","malikpr@mcmaster.ca",{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},"Yogita S Patel, BSc","patelys@mcmaster.ca",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"St. Josephs Healthcare Hamilton","RECRUITING","Hamilton","Ontario","L8N 4A6","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-79.84963,43.25011,{"lat":57,"lon":56},[60,61],{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},{"name":62,"role":33,"phone":21,"phoneExt":21,"email":21},"Wael C. Hanna, MDCM, MBA, FRCSC",{"type":33,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Wael Hanna","Director, Research Program, Boris Family Centre for Robotic Surgery","100358905","phase-1-synapse-3d-with-intravascular-indocyanine-green-100358905",false,"NCT03953144","Synapse 3D With Intravascular Indocyanine Green","Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial","Inclusion Criteria:\n\n* Tumour size \\\u003C3 cm\n* Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)\n* CT-imaging confirming that the tumour is confined to one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.\n\nExclusion Criteria:\n\n* Hypersensitivity or allergy to ICG, sodium iodide, or iodine\n* Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control.\n* Patients with clinical evidence of N1 or N2 disease on preoperative imaging\n* Pulmonary Function tests demonstrating Forced Expiratory Volume in 1s (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) less than or equal to 30% of predicted.","ALL","18 Years",{"count":76,"type":77},32,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.",[84,85],"Non-small Cell Lung Cancer","Primary Neoplasm",[87,88,89,90,91,92,93,94,28,95,96,97],"Segmentectomy","Lung Cancer","Robotic Surgery","3D Modelling","CT Imaging","Near-Infrared Fluorescence","IC-GREEN","Surgical Planning","Early-Stage Lung Cancer","Surgical Mapping","Lung Preservation","2026-01-29",{"date":100,"type":101},"2026-02-02","ACTUAL",{"date":103,"type":101},"2022-12-01",{"date":105,"type":77},"2026-12-31",{"name":5,"class":6},1]