[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648696":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Optical Surface Guidance + Open-Face Mask Group","EXPERIMENTAL","Patients undergo simulation and treatment using an open-face head-neck-shoulder thermoplastic mask. Before and during each fraction, the surface-guided system monitors the patient's surface position in real-time. Positioning is adjusted based on SGRT data and verified by pre-treatment CBCT.",[13],"Device: SGRT-guided radiotherapy with open thermoplastic mask immobilization",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Positioning + Closed Mask Group","ACTIVE_COMPARATOR","Patients undergo simulation and treatment using a standard closed head-neck-shoulder thermoplastic mask. Positioning is performed using traditional laser marks and skin tattoos, with position verified by pre-treatment CBCT. No optical surface system is used for active monitoring.",[19],"Device: Closed head-neck-shoulder thermoplastic mask with laser alignment",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","SGRT-guided radiotherapy with open thermoplastic mask immobilization",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Closed head-neck-shoulder thermoplastic mask with laser alignment",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Ye ling","CONTACT","(020)36997353","32600972@qq.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.25,23.11667,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":33,"phoneExt":25,"email":34},"Ye ling, Doctor",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100648696","sgrt-in-head-and-neck-cancer-radiotherapy-100648696",false,"NCT07726407","SGRT in Head and Neck Cancer Radiotherapy","A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy","Inclusion Criteria:\n\n* Age ≥ 18 years, \\\u003C75 years.\n* Histologically or cytologically confirmed head and neck malignant tumors （including nasopharynx, oropharynx, larynx, hypopharynx, oral cavity, etc.）.\n\nStage T1-4, N0-3, M0 （Stage I-IVa） according to AJCC 8th edition.\n\n* Planned to receive radical radiotherapy （with or without concurrent chemotherapy\u002F targeted therapy）.\n* Ability to tolerate breath-hold ≥ 30 seconds and to complete necessary couch shifts for patient positioning during a single breath-hold.\n\nExclusion Criteria:\n\n* Prior head and neck radiotherapy.\n* Brain tumor radiotherapy.\n* Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned.\n* Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study is a prospective, randomized, open-label, single-center exploratory trial. A total of 40 newly diagnosed, untreated head and neck cancer patients （stage I-IVa, AJCC 8th edition） will be enrolled and randomly assigned in a 1：1 ratio to either the experimental group or the control group. The experimental group will receive radiotherapy immobilization using optical surface guidance technology combined with an open-face mask, while the control group will undergo conventional positioning with a closed head-neck-shoulder thermoplastic mask. The primary objective is to compare the six-dimensional setup errors derived from cone-beam CT （CBCT） registration and intrafraction motion between the two groups. The secondary objective is to compare dosimetric parameters of organs at risk （including lens, eyeball, spinal cord, brainstem, temporal lobe, parotid gland, submandibular gland, thyroid gland, mandible, and temporomandibular joint） between the two groups. The safety of the optical surface-guided open-face mask technique will be evaluated by monitoring radiotherapy-related adverse effects during and after treatment. This study aims to investigate whether optical surface guidance combined with open-face immobilization can improve patient comfort, provide more precise radiotherapy, and enhance the protection of normal tissues.",[72,73],"Head and Neck Cancer","Radiotherapy, Conformal (IMRT)",[75,76,77],"head and neck cancer","optical surface guidance technology","radiotherapy","2026-07-22",{"date":80,"type":81},"2026-07-24","ACTUAL",{"date":83,"type":81},"2026-06-15",{"date":85,"type":66},"2028-12-30",{"name":5,"class":6},1]