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Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients (AFT-R)

2026년 6월 9일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

280

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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:

  • 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

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: DIEP reconstruction
절차: Deep inferior epigastric perforator flap
Deep inferior epigastric perforator flap as breast reconstruction
실험적: AFT
절차: Autologous fat transfer
Autologous fat transfer as total breast reconstruction

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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;
기간: 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.
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.
기간: 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
cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.
기간: 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.
12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Physical Well-being: Abdomen (BREAST-Q)
기간: 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.
12 months
Complications (Minor & General)
기간: 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
Oncologic Safety
기간: 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
기간: 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
기간: 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.
12 months
Breast Aesthetics & Volume
기간: 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.
12 months
Radiation-Associated Changes
기간: 12 months
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
12 months
Physical Well-being: Chest (BREAST-Q)
기간: 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)
기간: 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)
기간: 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.
12 months
Donor Site Satisfaction (BODY-Q)
기간: 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)
기간: 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.
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Maastricht University Medical Center

협력자

Academisch Ziekenhuis Maastricht

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 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2032년 7월 1일

연구 완료 (추정된)

2032년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NL-010887
  • 2025008144 (기타 보조금/기금 번호: Zorginstituut Nederland)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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위치

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