Recruiting

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)

ClinicalTrials.gov IDNCT07658170

PhaseNA

Enrollment30

SponsorThe Leningrad Regional Clinical Hospital

Age18 Years – 69 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Lipofilling, Fat Graft, Platelet Rich Plasma

About this study

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 questionnaires (BREASTQ) about their satisfaction and quality of life

Interventions

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. How it is prepared during surgery: About 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. How it is used: The lipobolus is placed directly into the cavity left after breast-conserving cancer surgery. This allows for immediate volume restoration in one operation. What makes it different: Standard fat grafting uses fat alone and often requires 2-3 procedures due to unpredictable abs

Primary outcomes

Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy (3 months after completion of radiotherapy)

Eligibility information

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.

Study locations

Leningrad Regional Clinical Hospital, Saint Petersburg, 188663 Russia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-08.