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)

The Leningrad Regional Clinical Hospital30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Lipofilling Fat Graft

Interventions

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

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy

Volume of the lipobolus that remains viable and engrafted, measured as a percentage of the originally implanted volume. The volume is assessed by breast ultrasound (US) performed 3 months after completion of adjuvant external beam radiotherapy (EBRT). The percentage is calculated as (volume at 3 months post-EBRT / immediate post-operative volume) × 100.

Time frame: 3 months after completion of radiotherapy

Secondary Outcomes

Patient Satisfaction with Aesthetic Results Measured by BREAST-Q

Change in patient-reported satisfaction and psychosocial well-being assessed using the validated BREAST-Q questionnaire. Two modules are used: (1) Satisfaction with Breasts module, and (2) Psychosocial Well-being module. Higher scores indicate better satisfaction and well-being.

Time frame: Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery

Frequency of Locoregional Recurrence and Distant Metastasis

The cumulative incidence of locoregional recurrence (recurrence of cancer in the ipsilateral breast, chest wall, or regional lymph nodes) and distant metastasis (spread of cancer to distant organs) during the observation period. Events are confirmed by imaging (mammography, ultrasound, MRI, or CT) and/or biopsy as clinically indicated.

Time frame: From the date of surgery through 12 months of follow-up (and continuing throughout the study observation period)

Dynamic Changes in Lipobolus Volume Assessed by Ultrasound

Change in lipobolus volume over time measured by breast ultrasound. Volume is calculated at each time point and compared to the immediate post-operative volume. Data are used to assess the pattern and rate of graft resorption or stability during the first year after surgery.

Time frame: 7 days after surgery; 1 month after radiotherapy; 3 months after radiotherapy; then every 3 months through 12 months post-surgery (i.e., at 6, 9, and 12 months after surgery)

Type and Frequency of Complications

The incidence of specific complications occurring after the lipobolus procedure and after radiotherapy. Complications assessed include: oil cysts, fat necrosis, seroma, hematoma, and infection. Events are documented by clinical examination and ultrasound imaging and graded according to CTCAE v5.0 where applicable.

Time frame: Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)