Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the… (NCT07658170) | Clinical Trial Compass
RecruitingNot Applicable
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)
Russia30 participantsStarted 2025-11-13
Plain-language 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
Who can participate
Age range
18 Years – 69 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 preven…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy
Timeframe: 3 months after completion of radiotherapy