Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients (NCT07641985) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients
Netherlands280 participantsStarted 2026-07-01
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares autologous fat grafting to DIEP flap reconstruction specifically in patients who've had radiation — given my radiation history, is my situation a good match for what this trial is studying, and which approach does my surgeon currently lean toward for me?
2The trial is listed as 'not yet recruiting,' so how far away might enrollment actually be, and is it realistic to wait for this study or should we be making a reconstruction decision sooner?
3The trial is measuring major complications that require reoperation or hospital readmission as a key outcome — based on my overall health and the extent of my radiation damage, how would my doctor assess my personal risk for those kinds of complications with each approach?
4Fat grafting typically requires multiple sessions to build up enough volume for full reconstruction — how many procedures might that realistically mean for me, and how does that timeline compare to having a single DIEP flap surgery outside of this trial?
5Since the trial will also measure cost-effectiveness, what should I understand about how my insurance currently covers DIEP flap versus fat grafting reconstruction, and could participating in a trial change what's covered for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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;
Timeframe: 12 months
2
to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission.
Timeframe: 12 months
3
cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.