[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Leningrad Regional Clinical Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28,29],"Breast Cancer","Lipofilling","Fat Graft","Platelet Rich Plasma","RECRUITING","2026-06-14",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2025-11-13",{"date":38,"type":20},"2028-06-03",{"name":40,"class":41},"The Leningrad Regional Clinical Hospital","OTHER_GOV",""]