Clinical Trial

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)

Study acronym: MINIPIG
Recruiting
View on ClinicalTrials.gov →
Summary
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
Trial Details
NCT Number NCT07658170
Lead Sponsor The Leningrad Regional Clinical Hospital
Conditions Breast Cancer, Lipofilling, Fat Graft, Platelet Rich Plasma
Enrollment 30 participants
Start Date 2025-11-13
Primary Completion 2026-01-13 (estimated)
Study Completion 2028-06-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-18