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

9 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

280

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
    • Limburg
      • Maastricht, Limburg, Olanda, 6229

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: DIEP reconstruction
Procedura: Deep inferior epigastric perforator flap
Deep inferior epigastric perforator flap as breast reconstruction
Sperimentale: AFT
Procedura: Autologous fat transfer
Autologous fat transfer as total breast reconstruction

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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;
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical Well-being: Abdomen (BREAST-Q)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Maastricht University Medical Center

Collaboratori

Academisch Ziekenhuis Maastricht

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2032

Completamento dello studio (Stimato)

1 luglio 2032

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL-010887
  • 2025008144 (Altro numero di sovvenzione/finanziamento: Zorginstituut Nederland)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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