Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fat Graft | — | UNRESOLVED | — |
| Lipofilling | — | UNRESOLVED | — |
| Platelet Rich Plasma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lipobolus for Breast Defect Reconstruction
- interventionNames
- Procedure: Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
Primary outcomes (1)
- measure
- Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy
- timeFrame
- 3 months after completion of radiotherapy
- description
- 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.
Secondary outcomes (4)
- measure
- Patient Satisfaction with Aesthetic Results Measured by BREAST-Q
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available