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)

NCT07658170 | Recruiting DMC

• 2 other identifiers: 11112025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer; Lipofilling; Fat Graft; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after completion of radiotherapy

Secondary Outcomes (4)

• Patient Satisfaction with Aesthetic Results Measured by BREAST-Q

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

• Frequency of Locoregional Recurrence and Distant Metastasis

  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

  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

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

Study Arms (1)

Lipobolus for Breast Defect Reconstruction

EXPERIMENTAL

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

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

Lipobolus for Breast Defect Reconstruction

Eligibility Criteria

• Age: 18 Years - 69 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Leningrad Regional Clinical Hospital: lead

Study Sites (1)

Leningrad Regional Clinical Hospital

Saint Petersburg, 188663, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: November 13, 2025
• Primary Completion: January 13, 2026
• Study Completion (Estimated): June 3, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

RU (1)