Breast CancerMINIPIGNCT07658170
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)
A study testing Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride) in people with Breast Cancer and Lipofilling, run by The Leningrad Regional Clinical Hospital at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Breast Cancer, Lipofilling, Fat Graft
- What is being tested?
- Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 13 Nov 2025to 3 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Leningrad Regional Clinical Hospital
Saint Petersburg, 188663
Aleksandr Bessonov, PhD, +79061300544, aa.bessonov@lokod.ru
About this study
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:
Read more
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
- Being tested
- Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Lipobolus for Breast Defect Reconstruction | Experimental | Not described Receives: Procedure: Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after completion of radiotherapy
Secondary outcomes (4)
Patient Satisfaction with Aesthetic Results Measured by BREAST-Q
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.
Measured: Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery
Frequency of Locoregional Recurrence and Distant Metastasis
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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start13 Nov 2025
- Primary completion13 Jan 2026
- Study completion3 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leningrad Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658170
- Sponsor's protocol ID
- 11
- Other IDs
- 112025
- Acronym
- MINIPIG
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07658170
- Acronym / sponsor ID
- MINIPIG / 11
- Conditions
- Breast Cancer, Lipofilling, Fat Graft, Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Leningrad Regional Clinical HospitalOther government
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 3 Jun 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipobolus for Breast Defect Reconstruction | Experimental | Procedure: Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- Male gender.
- ECOG ≥ 1.
- Multifocal or multicentric tumor.
- Grade G3.
- Triple-negative or HER2-positive tumor with uncontrolled disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Lipobolus for Breast Defect Reconstruction |
Primary outcome
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.
4 secondary outcomes
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
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride) in people with Breast Cancer and Lipofilling, run by The Leningrad Regional Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy (time frame: 3 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.