Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients (AFT-R)
2026年6月9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
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
280
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Limburg
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Maastricht、Limburg、オランダ、6229
- AzM
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コンタクト：
- Zoë MA Kuijlaars, MD
- 電話番号：0031629322886
- メール：zoe.kuijlaars@mumc.nl
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：DIEP reconstruction
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Deep inferior epigastric perforator flap as breast reconstruction
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実験的：AFT
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Autologous fat transfer as total breast reconstruction
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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;
時間枠：12 months
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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
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to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission.
時間枠：12 months
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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).
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12 months
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cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.
時間枠：12 months
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Well-being: Abdomen (BREAST-Q)
時間枠：12 months
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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
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Complications (Minor & General)
時間枠：12 months
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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).
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12 months
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Oncologic Safety
時間枠：12 months
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Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT's oncologic safety.
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12 months
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Sensory Recovery
時間枠：12 months
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Evaluate return of breast skin sensation at 12 months with mono-filament testing to compare sensory outcomes between techniques [in MUMC+ only].
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12 months
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Physical Function and Pain
時間枠：12 months
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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
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Breast Aesthetics & Volume
時間枠：12 months
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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
時間枠：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)
時間枠：12 months
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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.
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12 months
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Sexual Well-being (BREAST-Q)
時間枠：12 months
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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.
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12 months
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Breast Sensation (BREAST-Q)
時間枠：12 months
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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
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Donor Site Satisfaction (BODY-Q)
時間枠：12 months
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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.
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12 months
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Adverse Effects of Radiation (BREAST-Q)
時間枠：12 months
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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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2032年7月1日
研究の完了 (推定)
2032年7月1日
試験登録日
最初に提出
2026年5月12日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NL-010887
- 2025008144 (その他の助成金/資金番号：Zorginstituut Nederland)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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