Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients (AFT-R)
2026年8月19日 更新者：Maastricht University Medical Center
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients
The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are:
Does AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients?
Researchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients.
Participants will:
Undergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
280
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Limburg
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Maastricht、Limburg、荷兰、6229
- 招聘中
- AzM
-
接触：
- Zoë MA Kuijlaars, MD
- 电话号码：0031629322886
- 邮箱：zoe.kuijlaars@mumc.nl
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Female, aged >18 years.
- BMI between > 22 and <35 kg/m2
- History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).
- May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation.
- Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.
- Medically fit for surgery (ASA I-III).
- Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).
- No evidence of active cancer at enrollment; remission confirmed.
- Able to wear the EVE device (if randomized in AFT).
- Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.
Exclusion Criteria:
- Prior autologous breast reconstruction on the intended side. BMI <22 or >35 kg/m2
- Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).
- Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).
- Current chemotherapy or completed less than 4 weeks prior to enrollment.
- Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).
- Active smoker or not abstinent for at least 6 weeks pre-operatively.
- Pregnant at time of enrollment.
- In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).
- Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).
- Allergy to lidocaine or silicone
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：DIEP reconstruction
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Deep inferior epigastric perforator flap as breast reconstruction
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实验性的：AFT
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Autologous fat transfer as total breast reconstruction
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
to determine whether autologous fat transfer (AFT) is non-inferior to DIEP flap breast re-construction regarding breast satisfaction, as measured by the BREAST-Q, 12 months after the final reconstructive procedure in irradiated breast cancer patients;
大体时间：12 months
|
One of the primary outcomes is the BREAST-Q "Satisfaction with Breasts" score at 12 months post-reconstruction.
This validated, patient-reported measure (0-100 scale) as-sesses satisfaction with breast appearance and feel.
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12 months
|
|
to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission.
大体时间：12 months
|
The second primary outcome measure is the incidence of major complications (i.e.
complications requiring reoperation or hospital readmission such as hematoma, venous/arterial insufficiency, partial/total flap loss, and infection/abscess).
|
12 months
|
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cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.
大体时间：12 months
|
The third primary outcome is cost-effective-ness.
We will collect detailed healthcare and societal costs per patient using hospital records, CRFs, and a study-adapted patient-reported iMCQ and iPCQ (for health care resource use and productivity loss).
QALYs will be calculated from EQ-5D-5L data at multiple timepoints.
We will compare cost per QALY (ICER) between AFT and DIEP, and conduct a budget impact analysis.
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12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Well-being: Abdomen (BREAST-Q)
大体时间：12 months
|
Physical Well-being: Abdomen (donor site), assessed using the BREAST-Q Reconstruction Module.
Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the abdominal donor site.
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12 months
|
|
Complications (Minor & General)
大体时间：12 months
|
Incidence of minor recipient-site and donor-site com-plications (i.e.
complications taking care of at the outpatient clinic) managed conserva-tively (e.g.
wound problems/dehiscence, infection, seroma, hematoma, and abdominal bulging), and any general (systemic) complications related to surgery or hospitalization (e.g.
pulmonary embolism, pneumonia).
|
12 months
|
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Oncologic Safety
大体时间：12 months
|
Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT's oncologic safety.
|
12 months
|
|
Sensory Recovery
大体时间：12 months
|
Evaluate return of breast skin sensation at 12 months with mono-filament testing to compare sensory outcomes between techniques [in MUMC+ only].
|
12 months
|
|
Physical Function and Pain
大体时间：12 months
|
We will assess post-mastectomy pain and phantom sensations using relevant BREAST-Q items or a brief questionnaire.
For donor site function, DIEP patients may be asked about core strength (e.g.
sit-ups), while AFT patients will be monitored for minor issues like contour irreg-ularities.
Assessments will be based on patient reports and clinical exam.
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12 months
|
|
Breast Aesthetics & Volume
大体时间：12 months
|
Breast volume and shape assessed 12 months after reconstruction using 3D Vectra photography and the BREAST-V volume calculator (https://braflap.com/breast-v/,
Sternal Notch - Nipple distance [cm], Fold Projection - Inframammary Fold distance [cm], and Nipple - Inframammary Fold distance [cm]) .
Fat graft retention in the AFT group will be estimated by total grafted volume versus final breast volume.
Standardized photographs (2D and 3D) will document cosmetic out-comes which can be assessed by a an expert panel.
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12 months
|
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Radiation-Associated Changes
大体时间：12 months
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We will grade radiation fibrosis/telangiectasia in the chest skin at baseline (just before recon) and at 12 months, using the Common Terminology Criteria for Adverse Events (CTCAE) score (for radiation dermatitis/fibrosis).
If AFT improves the pliability or vascularity of skin, we might see an improvement in grade (e.g. from CTCAE 2 to 1).
If DIEP flap breast reconstruction brings fresh skin, the radiated skin might be partially replaced or supplemented.
This is some-what subjective, but we will attempt consistent grading.
Also, if any ulcers or non-healing radi-ation damage was present, we will see if healed after reconstruction
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12 months
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Physical Well-being: Chest (BREAST-Q)
大体时间：12 months
|
Physical Well-being: Chest, assessed using the BREAST-Q Reconstruction Module.
Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the chest.
|
12 months
|
|
Sexual Well-being (BREAST-Q)
大体时间：12 months
|
Sexual Well-being, assessed using the BREAST-Q Reconstruction Module.
Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better sexual well-being.
|
12 months
|
|
Breast Sensation (BREAST-Q)
大体时间：12 months
|
Breast Sensation, assessed using the BREAST-Q Sensation Module.
Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better breast sensation.
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12 months
|
|
Donor Site Satisfaction (BODY-Q)
大体时间：12 months
|
Satisfaction with donor site appearance, assessed using the BODY-Q.
Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating greater satisfaction with the donor site.
|
12 months
|
|
Adverse Effects of Radiation (BREAST-Q)
大体时间：12 months
|
Adverse Effects of Radiation, assessed using the BREAST-Q Reconstruction Module.
Scores are transformed to a scale ranging from 0 to 100.
Specify according to the scoring manual whether higher scores indicate fewer or more adverse effects of radiation.
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12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月1日
初级完成 (估计的)
2032年7月1日
研究完成 (估计的)
2032年7月1日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年6月1日
更多信息
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