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)

Обзор

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

Вмешательства

• Процедура 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-lik

Первичные конечные точки

• Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy [Срок оценки: 3 months after completion of radiotherapy]

Вторичные конечные точки (4)

• Patient Satisfaction with Aesthetic Results Measured by BREAST-Q [Срок оценки: Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery]
• Frequency of Locoregional Recurrence and Distant Metastasis [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Leningrad Regional Clinical Hospital — Saint Petersburg

Идентификаторы

NCT: NCT07658170 · 11 · 112025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗