[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519776":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":39,"responsibleParty":65,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":95,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SRS group","EXPERIMENTAL","Participants in the SRS group will receive the intervention described earlier, consisting of a Gamma Knife radiosurgery, and undergo the same follow-up exams (radiological and clinical) as participants of the control group.",[13],"Procedure: Stereotactic RadioSurgery (SRS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The medical care will consist of observation for any element that may indicate an increased risk of rupture, like aneurysm growth or instability in shape.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Stereotactic RadioSurgery (SRS)","All treatments will be performed using the Gamma Knife Perfexion or Icon system (Elekta). The following treatment parameters will be used:\n\n* The head will be immobilized using a stereotactic Leksell Model G frame, installed using local protocols\n* Targeting will be performed by using a stereotactic CTA. No MRI will be performed.\n* Only one aneurysm will be treated per patient\n* The aneurysm, including its neck, will be contoured and targeted using a combination of 4mm isocenters as deemed appropriate by the treating team\n* A prescription dose of 25 Gy at the margin of the target will be used\n* The maximal dose on optic pathways will be kept below 10 Gy\n* The brainstem 12-Gy volume will be kept below 1cc",[9],[26],"Gamma Knife SRS",[28],{"name":29,"affiliation":30,"role":31},"David Mathieu, MD FRCS(C)","Service de neurochirurgie, Département de chirurgie, Centre hospitalier universitaire de Sherbrooke","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"David Mathieu, M.D. FRCS(C)","CONTACT","819-346-1110","73324","david.mathieu@USherbrooke.ca",[40],{"facility":41,"status":18,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Centre Hospitalier Universitaire de Sherbrooke","Sherbrooke","Quebec","J1H 5N4","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-71.89908,45.40008,{"lat":51,"lon":50},[54,56,58,61,63],{"name":55,"role":35,"phone":36,"phoneExt":37,"email":38},"David Mathieu, M.D., Ph.D.",{"name":57,"role":31,"phone":18,"phoneExt":18,"email":18},"David Mathieu, M.D.",{"name":59,"role":60,"phone":18,"phoneExt":18,"email":18},"Elizabeth Adam","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":18,"phoneExt":18,"email":18},"Khaled Effendi, M.D.",{"name":64,"role":60,"phone":18,"phoneExt":18,"email":18},"Christian Iorio-Morin, M.D. Ph.D.",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Dr David Mathieu","Director of the Division of Neurosurgery",[70,72],{"name":71,"class":6},"Université de Sherbrooke",{"name":5,"class":6},"100519776","brain-low-risk-aneurysm-stereotactic-radiosurgical-trial-100519776",false,"NCT06047951","Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial","Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial: A Phase 2 Nonrandomized Controlled Trial","BLAST","Inclusion Criteria:\n\n* Medical imaging (CTA, MRA or digital substraction angiography) reveals the existence of an asymptomatic unruptured saccular anterior circulation intracranial aneurysm under 7 mm\n* Advised by a vascular neurosurgeon to observe rather than undergo endovascular or microsurgical management\n\nExclusion Criteria:\n\n* Prior history of aneurysmal rupture\n* Presence of symptoms that could be attributed to the aneurysm (severe headache, third cranial nerve deficits, or others)\n* Imaging features deemed to increase rupture risk as evaluated by the treating physician\n* Posterior circulation aneurysm\n* Fusiform aneurysm\n* Dissecting aneurysm\n* Mycotic aneurysm\n* Direct contact between the aneurysm and the optic pathways on medical imaging\n* Prior coils or clips in the targeted aneurysm or any other aneurysm\n* Patient unable to consent\n* Patient unable or unlikely to comply with the follow-up schedule","ALL","18 Years","75 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans.\n\nParticipants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions:\n\nDay 0\n\n* Initial questionnaire\n* CTA scan\n* MRI\n* Radiosurgery performed on patients in the radiosurgery group\n\n  6 months\n* CTA scan\n* Follow-up questionnaire\n\n  12 months\n* CTA scan\n* MRI\n* Follow-up questionnaire\n\n  24 months\n* CTA scan\n* Follow-up questionnaire\n\n  36 months\n* CTA scan\n* MRI\n* Follow-up questionnaire\n\nResearchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.",[92],"Intracranial Aneurysm",[94],"brain aneurysm, radiosurgery, intracranial aneurysm","NOT_YET_RECRUITING","2025-02-12",{"date":98,"type":99},"2025-02-14","ACTUAL",{"date":101,"type":86},"2025-06",{"date":103,"type":86},"2030-06",{"name":67,"class":6},1]