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)
2026년 6월 14일 업데이트: 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
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Saint Petersburg, 러시아 제국, 188663
- 모병
- Leningrad Regional Clinical Hospital
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연락하다:
- Aleksandr Bessonov, PhD
- 전화번호: +79061300544
- 이메일: aa.bessonov@lokod.ru
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Lipobolus for Breast Defect Reconstruction
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy
기간: 3 months after completion of radiotherapy
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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.
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3 months after completion of radiotherapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Satisfaction with Aesthetic Results Measured by BREAST-Q
기간: Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery
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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.
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Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery
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Frequency of Locoregional Recurrence and Distant Metastasis
기간: From the date of surgery through 12 months of follow-up (and continuing throughout the study observation period)
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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.
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From the date of surgery through 12 months of follow-up (and continuing throughout the study observation period)
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Dynamic Changes in Lipobolus Volume Assessed by Ultrasound
기간: 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)
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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.
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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)
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Type and Frequency of Complications
기간: Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)
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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.
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Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 11월 13일
기본 완료 (실제)
2026년 1월 13일
연구 완료 (추정된)
2028년 6월 3일
연구 등록 날짜
최초 제출
2026년 6월 14일
QC 기준을 충족하는 최초 제출
2026년 6월 14일
처음 게시됨 (실제)
2026년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 14일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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