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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)

RecruitingNAAges 18 Years - 69 YearsFemaleThe Leningrad Regional Clinical Hospital
NCT07658170 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The main questions it aims to answer are: What percentage of the fat graft's volume remains in place 3 months after radiation therapy? What is the safety of this procedure, including its side effects and any impact on cancer returning? Participants will: * Undergo standard breast-conserving surgery to remove the tumor * Have liposuction (fat removal) from their own belly or thighs * Receive a "lipobolus" (their own fat mixed with PRF) placed into the breast defect during the same surgery * Follow up for 12 months with ultrasound scans, physical exams, and questionnai

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically verified breast cancer (BC). * Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition). * Tumor grade G1 or G2. * Estrogen receptor positivity (ER+). * ECOG performance status = 0. * Primary tumor size up to 2 cm, based solely on preoperative examination data (mammography, ultrasound, MRI). * Indications for breast-conserving surgery (BCS) with a breast resection extent determined by a multidisciplinary oncology board. * Submission of an informed voluntary consent (IVC) regarding participation in the study. * Ability to understand and comply with the requirements of the study protocol. Exclusion Criteria: * Male gender. * ECOG ≥ 1. * Multifocal or multicentric tumor. * Grade G3. * Triple-negative or HER2-positive tumor with uncontrolled disease. * Stage cT3 or higher or distant metastases (M1). * Inflammatory breast cancer. * Prior neoadjuvant chemotherapy or hormonal therapy. * Prior radiation therapy to the breast. * Presence of blood coagulation disorders (coagulopathy, thrombocytopathy, thrombocytopenia \< 100 × 10⁹/L). * Taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued. * Presence of active infectious diseases. * Acute autoimmune diseases. * Decompensated comorbidities (diabetes mellitus, cardiovascular diseases, etc.). * Body mass index (BMI) \< 18.5 kg/m² (insufficient adipose tissue volume for liposuction). * Pregnancy or lactation. * Mental illnesses that prevent informed consent. * Known allergy to local anesthetics or sodium citrate.
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What it tests

  • Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
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Where

1 site
Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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