NCT07658170招募中不适用
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 Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically verified breast cancer (BC).
- •Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition).
- •Tumor grade G1 or G
- •Estrogen receptor positivity (ER+).
- •ECOG performance status =
- •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.
排除标准
- •Male gender.
- •Multifocal or multicentric tumor.
- •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.
研究者
研究点 (1)
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