[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641341":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":40,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":11,"overallStatus":23,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"The Leningrad Regional Clinical Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lipobolus for Breast Defect Reconstruction","EXPERIMENTAL",null,[13],"Procedure: Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"PROCEDURE","Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)","The intervention is a single surgical procedure using a \"lipobolus\" - a modified fat graft made from the participant's own tissues to restore breast shape after cancer surgery.\n\nHow it is prepared during surgery:\n\nAbout 200 mL of fat is harvested from the participant's belly using liposuction. Separately, 60 mL of blood is drawn and spun in a centrifuge to obtain platelet-rich plasma (PRP). The fat, PRP, and calcium chloride are mixed. Calcium chloride activates the PRP, forming a thick, gel-like fibrin scaffold that traps the fat fragments into a single, stable block.\n\nHow it is used:\n\nThe lipobolus is placed directly into the cavity left after breast-conserving cancer surgery. This allows for immediate volume restoration in one operation.\n\nWhat makes it different:\n\nStandard fat grafting uses fat alone and often requires 2-3 procedures due to unpredictable abs",[9],[21],{"facility":22,"status":23,"city":24,"state":11,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Leningrad Regional Clinical Hospital","RECRUITING","Saint Petersburg","188663","Russia","RU",{"type":29,"coordinates":30},"Point",[31,32],30.31413,59.93863,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Aleksandr Bessonov, PhD","CONTACT","+79061300544","aa.bessonov@lokod.ru",{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100641341","evaluation-of-the-efficacy-and-safety-of-using-platelet-rich-fibrin-prf-based-lipobolus-for-the-immediate-reconstruction-of-defects-after-breast-conserving-resection-for-breast-cancer-minimally-invasive-primary-immediate-grafting-100641341",false,"NCT07658170","Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)","MINIPIG","Inclusion Criteria:\n\n* Histologically verified breast cancer (BC).\n* Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition).\n* Tumor grade G1 or G2.\n* Estrogen receptor positivity (ER+).\n* ECOG performance status = 0.\n* Primary tumor size up to 2 cm, based solely on preoperative examination data (mammography, ultrasound, MRI).\n* Indications for breast-conserving surgery (BCS) with a breast resection extent determined by a multidisciplinary oncology board.\n* Submission of an informed voluntary consent (IVC) regarding participation in the study.\n* Ability to understand and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n* Male gender.\n* ECOG ≥ 1.\n* Multifocal or multicentric tumor.\n* Grade G3.\n* Triple-negative or HER2-positive tumor with uncontrolled disease.\n* Stage cT3 or higher or distant metastases (M1).\n* Inflammatory breast cancer.\n* Prior neoadjuvant chemotherapy or hormonal therapy.\n* Prior radiation therapy to the breast.\n* Presence of blood coagulation disorders (coagulopathy, thrombocytopathy, thrombocytopenia \\\u003C 100 × 10⁹\u002FL).\n* Taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued.\n* Presence of active infectious diseases.\n* Acute autoimmune diseases.\n* Decompensated comorbidities (diabetes mellitus, cardiovascular diseases, etc.).\n* Body mass index (BMI) \\\u003C 18.5 kg\u002Fm² (insufficient adipose tissue volume for liposuction).\n* Pregnancy or lactation.\n* Mental illnesses that prevent informed consent.\n* Known allergy to local anesthetics or sodium citrate.","FEMALE","18 Years","69 Years",{"count":53,"type":54},30,"ESTIMATED","INTERVENTIONAL",[57],"NA","The goal of this clinical trial is to learn if a special type of fat graft, made by mixing a person's own fat with platelet-rich fibrin (PRF), works to fix breast shape defects after cancer surgery. PRF is a substance made from a person's own blood that is rich in growth factors, which may help the graft survive better.\n\nThe main questions it aims to answer are:\n\nWhat percentage of the fat graft's volume remains in place 3 months after radiation therapy?\n\nWhat is the safety of this procedure, including its side effects and any impact on cancer returning?\n\nParticipants will:\n\n* Undergo standard breast-conserving surgery to remove the tumor\n* Have liposuction (fat removal) from their own belly or thighs\n* Receive a \"lipobolus\" (their own fat mixed with PRF) placed into the breast defect during the same surgery\n* Follow up for 12 months with ultrasound scans, physical exams, and questionnaires (BREASTQ) about their satisfaction and quality of life",[60,61,62,63],"Breast Cancer","Lipofilling","Fat Graft","Platelet Rich Plasma","2026-06-14",{"date":66,"type":67},"2026-06-18","ACTUAL",{"date":69,"type":67},"2025-11-13",{"date":71,"type":54},"2028-06-03",{"name":5,"class":6},1]