[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631671":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":51,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Royal College of Surgeons, Ireland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CNS Surveillance","EXPERIMENTAL","Participants undergo a baseline contrast-enhanced brain MRI. Those without radiologic evidence of CNS metastases are randomized to receive structured CNS surveillance consisting of repeat brain MRI at 6 months and 12 months after baseline. If CNS metastases are detected at any time, management is according to standard clinical practice.",[13],"Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) with Contrast",{"label":15,"type":16,"description":17,"interventionNames":18},"No Routine CNS Surveillance (Standard of Care)","ACTIVE_COMPARATOR","Participants undergo a baseline contrast-enhanced brain MRI. Those without radiologic evidence of CNS metastases are randomized to no routine surveillance imaging. Subsequent brain imaging is performed only if clinically indicated based on symptoms or clinician judgment. Management of any detected CNS metastases follows standard clinical practice.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Brain Magnetic Resonance Imaging (MRI) with Contrast","Contrast-enhanced MRI of the brain performed according to local institutional standards. In the surveillance arm, MRI is performed at baseline, 6 months, and 12 months. In the standard-of-care arm, MRI is performed at baseline only, with additional imaging if clinically indicated.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Carlo Palmieri, MD, PHD","CONTACT","018093000","cpalmi@liverpool.ac.uk",[33],{"facility":34,"status":35,"city":36,"state":25,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Beaumont RCSI Cancer Centre","RECRUITING","Beaumont","Ireland","IE",{"type":40,"coordinates":41},"Point",[42,43],-6.22713,53.38721,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":25,"phoneExt":25,"email":48},"Prof Leonie Young, PhD","lyoung@rcsi.com",{"type":50,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[52,54],{"name":53,"class":6},"The Clatterbridge Cancer Centre NHS Foundation Trust",{"name":55,"class":6},"Royal Marsden NHS Foundation Trust","100631671","survey-cns-a-feasibility-study-of-randomising-women-and-men-with-her2-positive-metastatic-breast-cancer-to-central-nervous-system-surveillance-versus-no-surveillance-100631671",false,"NCT07503717","SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance","SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla","SURVEY-CNS","Inclusion Criteria:\n\n* Age ≥18 years\n* Male or female\n* Histologically or cytologically confirmed HER2-positive breast cancer\n* Evidence of metastatic breast cancer\n* Estrogen receptor (ER) positive or negative disease permitted\n* Presence of visceral metastatic disease\n* Receiving active HER2-directed systemic therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Estimated life expectancy greater than 6 months\n* Ability to provide written informed consent\n* Willing and able to comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Prior history of brain metastases\n* History or evidence of leptomeningeal carcinomatosis\n* Symptoms suggestive of brain metastases at screening\n* Bone-only metastatic disease\n* Inability to undergo MRI scanning\n* Known hypersensitivity or contraindication to MRI contrast agents that cannot - be managed per local standard of care\n* Significant medical condition or laboratory abnormality that, in the opinion of - the investigator, makes participation inappropriate Inability to provide informed consent\n* Deemed unsuitable for participation by the principal investigator due to clinical, mobility, or social circumstances","ALL","18 Years",{"count":67,"type":68},69,"ESTIMATED","INTERVENTIONAL",[71],"NA","SURVEY-CNS is a feasibility study evaluating whether women and men with HER2-positive metastatic breast cancer can be successfully recruited and randomised to a strategy of central nervous system (CNS) magnetic resonance imaging (MRI) surveillance versus standard of care (no routine CNS surveillance).\n\nPatients with HER2-positive metastatic breast cancer have a high risk of developing brain metastases. Brain metastases can cause significant symptoms, including headache, nausea, seizures, visual disturbance, motor dysfunction, and cognitive or psychological changes. Although new HER2-directed therapies have improved systemic disease control, CNS progression remains common and is associated with reduced quality of life and survival.\n\nCurrently, routine brain imaging is not recommended in asymptomatic patients. Brain imaging is typically performed only when neurological symptoms develop. Observational data suggest that patients diagnosed with asymptomatic brain metastases may have better outcomes than those diagnosed after symptoms occur. However, it is not known whether a surveillance strategy is feasible or acceptable to patients.\n\nAll participants in this study will undergo a baseline contrast-enhanced brain MRI. Patients without evidence of CNS metastases on the baseline scan will be randomised (1:1) to either:\n\nCNS surveillance with repeat brain MRI at 6 and 12 months, or No routine surveillance imaging (standard of care), with imaging only if clinically indicated.\n\nThe primary objective is to determine whether more than 30% of eligible patients approached agree to undergo screening and randomisation. The study will approach up to 193 patients and will be considered feasible if 69 patients consent to screening with intent to randomise.\n\nSecondary objectives include:\n\nDetermining the proportion of patients with previously undetected (occult) CNS metastases at baseline; Determining the incidence of occult CNS metastases during surveillance; Recording symptomatic CNS presentations; Describing management of CNS metastases, including surgery or radiotherapy. Participants will be followed for 14 months from baseline.",[74,75],"Breast Cancer","HER2-Positive Metastatic Breast Cancer","2026-03-26",{"date":78,"type":79},"2026-03-31","ACTUAL",{"date":81,"type":79},"2025-06-01",{"date":83,"type":68},"2028-06-01",{"name":5,"class":6},1]