[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564276":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":68,"collaborators":13,"id":70,"slug":13,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":13,"enrollmentInfo":79,"targetDuration":13,"studyType":82,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":52,"whyStopped":13,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Center Eugene Marquis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Measurement patient displacement during surface-guided radiotherapy sessions","Average length of linear translation vector during session (measured by surface cameras) over all sessions performed","Through study completion, an average of 1 year",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.\n\nAt the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.\n\nHowever, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.\n\nThe study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Surface Guided RadioTherapy without face mask","EXPERIMENTAL","Radiotherapy sessions will be carried out using the surface camera system, replacing the restraint mask.\n\nSelf-assessment questionnaires will also be completed by healthcare professionals concerning the level of difficulty encountered during each SGRT session without mask.\n\nSkin side effects are recorded by the radiotherapist during weekly follow-up consultations.\n\nAt the end of treatment, patients complete a patient experience questionnaire.",[27],"Procedure: Surface Guided RadioTherapy (SGRT) without mask",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"PROCEDURE","Surface Guided RadioTherapy (SGRT) without mask","Firstly, patients are positioned in a vacuum mattress that moulds their head, neck and shoulders for a reference scan.\n\nDuring the treatment sessions, patients are positioned according to the reference scan, using the surface camera system.\n\nOnce the observed offsets have been applied, the patient's surface is captured. Treatment can then begin, with continuous monitoring of displacements by the surface camera system. Automatic beam interruption is provided during treatment in the event of motion detection exceeding the standard tolerance threshold (\\>3 mm).\n\nIf the use of a thermoformed mask during your treatment prove necessary, for whatever reason, will not result in a halt to the research.\n\nPatients receive between 10 and a max of 35 radiotherapy sessions. The follow-up period begins after the last radiotherapy session, and patients are assessed at 4 or 6 weeks and at 3 months by a radiotherapist.",[23],[35],{"name":36,"affiliation":37,"role":38},"Coralie Geffroy","Centre de Lutte contre le Cancer Eugène Marquis","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Marion Trochet","CONTACT","02 99 25 31 65","+33","m.trochet@rennes.unicancer.fr",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Valérie Jolaine","02 99 25 30 36","v.jolaine@rennes.unicancer.fr",[51],{"facility":37,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Rennes","Brittany Region","35042","France","FR",{"type":59,"coordinates":60},"Point",[61,62],-1.67431,48.11109,{"lat":62,"lon":61},[65],{"name":36,"role":42,"phone":66,"phoneExt":44,"email":67},"0299253139","c.hulot@rennes.unicancer.fr",{"type":69,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100564276",false,"NCT06627075","Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer","Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer","SUGAR","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer\n* Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35\n* Patients who have dated and signed an informed consent form\n\nExclusion Criteria:\n\n* Patients with uncontrollable movements\n* Patients under psychiatric care\n* Patients who do not understand or read French\n* Patients participating in an interventional study testing another medical intervention\n* Patients under guardianship, curatorship, safeguard of justice or deprived of liberty\n* Pregnant or breast-feeding women\n* Patients without social security coverage","ALL","18 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[15],"The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.",[86],"Otorhinolaryngeal Cancer",[88,89],"Radiotherapy","Optical surface guidance","2025-02-11",{"date":92,"type":93},"2025-02-13","ACTUAL",{"date":95,"type":93},"2024-12-12",{"date":97,"type":81},"2027-01-12",{"name":5,"class":6},1]