[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601101":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Saint Petersburg State University, Russia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Carbon Suspension (Black Eye) Marking","EXPERIMENTAL",null,[13],"Procedure: Ultrasound-guided carbon suspension (Black Eye) injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Metallic Marker (TWIRL ULTRACOR) Placement","ACTIVE_COMPARATOR",[18],"Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Ultrasound-guided carbon suspension (Black Eye) injection","Under ultrasound guidance, 0.5 mL of sterile carbon particle suspension (Black Eye) is injected into the capsule of the metastatic axillary lymph node(s).\n\nTechnique: Performed using a high-frequency linear ultrasound probe (e.g., 12 MHz) and a 22G needle.\n\nTarget: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of neoadjuvant systemic therapy (NST).\n\nRationale:\n\nCarbon suspension provides long-term visual localization due to its black staining properties.\n\nInert and biocompatible, with minimal risk of allergic reactions. Patients proceed to standard NST based on tumor subtype (chemotherapy, targeted therapy, or endocrine therapy).\n\nPost-NST imaging (ultrasound, CT, or PET-CT) to assess treatment response.\n\nSurgical Intervention:\n\nTargeted axillary dissection (TAD) with removal of marked nodes + sentinel lymph node biopsy (SLNB) using fluorescent dye.\n\nIntraoperative frozen section analysis (hematoxylin \\& eosin staining) of excised nodes.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement","A 4-mm nitinol (nickel-titanium alloy) marker (TWIRL ULTRACOR) is deployed into the metastatic lymph node(s) under ultrasound guidance.\n\nTechnique: Uses a specialized introducer kit for precise placement. Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of NST.\n\nRationale:\n\nNitinol markers are radiopaque, MRI-compatible, and resistant to migration. Standard method for tumor localization in breast cancer.\n\nPost-Marking Protocol:\n\nIdentical NST and imaging follow-up as Group 1.\n\nSurgical Intervention:\n\nTAD with marker localization (palpation\u002Fimaging-guided excision) + SLNB. Intraoperative frozen section analysis.",[15],[30],{"name":31,"affiliation":5,"role":32},"Alina A Olchonova, Physician","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","+79818197785","dr.lazakovich@gmail.com",[39],{"facility":40,"status":41,"city":42,"state":11,"zip":11,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"St. Petersburg State University","RECRUITING","Saint Petersburg","Russia","RU",{"type":46,"coordinates":47},"Point",[48,49],30.31413,59.93863,{"lat":49,"lon":48},[52],{"name":40,"role":35,"phone":53,"phoneExt":11,"email":54},"+7 (812) 363-60-00","spbu@spbu.ru",{"type":32,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Alina Olchonova","Principal Investigator","100601101","carbon-suspension-vs-metallic-marker-for-axillary-lymph-node-marking-in-breast-cancer-after-neoadjuvant-therapy-100601101",false,"NCT07106112","Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy","A Randomized Trial Comparing Carbon Suspension (Black Eye) and Metallic Markers (TWIRL ULTRACOR) for Localization of Metastatic Axillary Lymph Nodes Prior to Neoadjuvant Systemic Therapy in Breast Cancer Patients.","COMET","Inclusion Criteria:\n\n* Women ≥18 years.\n* Morphologically confirmed breast cancer (T1-3N1M0).\n* ECOG 0-1.\n* Indication for neoadjuvant therapy.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* No lymph node regression post-neoadjuvant therapy (persistent N1).\n* Distant metastasis progression.\n* Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).","FEMALE","18 Years",{"count":69,"type":70},110,"ESTIMATED","INTERVENTIONAL",[73],"NA","This single-center, randomized study aims to compare the intraoperative detection rates of axillary lymph nodes marked with carbon suspension versus metallic markers in breast cancer patients (T1-3N1M0) before neoadjuvant therapy. Primary endpoint: frequency of marked lymph node identification during surgery. Secondary endpoints: time from marking to surgery and quality of life (EORTC QLQ-BR23).",[76],"Breast Cancer",[78,79,80,81,82],"Carbon suspension","Axillary lymph node marking","Neoadjuvant therapy","Targeted axillary dissection","Metallic marker","2025-08-02",{"date":85,"type":86},"2025-08-06","ACTUAL",{"date":88,"type":86},"2025-05-15",{"date":90,"type":70},"2026-12-31",{"name":5,"class":6},1]