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) (MINIPIG)

June 14, 2026 updated by: The Leningrad Regional Clinical Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Saint Petersburg, Russia, 188663
        • Recruiting
        • Leningrad Regional Clinical Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lipobolus for Breast Defect Reconstruction
Procedure: 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-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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy
Time Frame: 3 months after completion of 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction with Aesthetic Results Measured by BREAST-Q
Time Frame: Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery
Change in patient-reported satisfaction and psychosocial well-being assessed using the validated BREAST-Q questionnaire. Two modules are used: (1) Satisfaction with Breasts module, and (2) Psychosocial Well-being module. Higher scores indicate better satisfaction and well-being.
Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery
Frequency of Locoregional Recurrence and Distant Metastasis
Time Frame: From the date of surgery through 12 months of follow-up (and continuing throughout the study observation period)
The cumulative incidence of locoregional recurrence (recurrence of cancer in the ipsilateral breast, chest wall, or regional lymph nodes) and distant metastasis (spread of cancer to distant organs) during the observation period. Events are confirmed by imaging (mammography, ultrasound, MRI, or CT) and/or biopsy as clinically indicated.
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
Time Frame: 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)
Change in lipobolus volume over time measured by breast ultrasound. Volume is calculated at each time point and compared to the immediate post-operative volume. Data are used to assess the pattern and rate of graft resorption or stability during the first year after surgery.
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
Time Frame: Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)
The incidence of specific complications occurring after the lipobolus procedure and after radiotherapy. Complications assessed include: oil cysts, fat necrosis, seroma, hematoma, and infection. Events are documented by clinical examination and ultrasound imaging and graded according to CTCAE v5.0 where applicable.
Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Leningrad Regional Clinical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11
  • 112025 (Other Identifier: The Leningrad Regional Clinical Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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