An interventional study of Autologous fat transfer and Deep inferior epigastric perforator flap in Breast Cancer, Breast Reconstruction and Breast Reconstruction After Mastectomy, sponsored by Maastricht University Medical Center. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
Among 24 studies in Breast Neoplasms by Maastricht University Medical Center — 7 open to participants now, 8 under way, none of them phase 3. Breast Neoplasms · Maastricht University Medical Center.
Among the 24 studies in Breast Neoplasms by Maastricht University Medical Center, this one is the 3rd largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2026, is one of 11 with no phase, and was the 24th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →7 of the 24 studies in Breast Neoplasms by Maastricht University Medical Center are open now, in 1 country. Recruiting first, the newest first:
Maastricht University Medical Center · Sites in Netherlands
Maastricht University Medical Center · Sites in Netherlands
Maastricht University Medical Center · Sites in Netherlands
Maastricht University Medical Center · Sites in Netherlands
Maastricht University Medical Center · Sites in Netherlands
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 280 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 71 across the 14 interventional studies, 86 across the 9 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
2 of the studies in Breast Neoplasms by Maastricht University Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06335069Maastricht University Medical Center18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer. | 2027-03 |
| NCT04486495Maastricht University Medical CenterMinimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer | 2027-07-01 |
Among the 24 studies in Breast Neoplasms by Maastricht University Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Deep inferior epigastric perforator flap
Procedure: Autologous fat transfer
Autologous fat transfer as total breast reconstruction
Deep inferior epigastric perforator flap as breast reconstruction
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;
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.
Time frame: 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.
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).
Time frame: 12 months
cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.
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.
Time frame: 12 months
Physical Well-being: Abdomen (BREAST-Q)
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.
Time frame: 12 months
Complications (Minor & General)
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).
Time frame: 12 months
Oncologic Safety
Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT's oncologic safety.
Time frame: 12 months
Sensory Recovery
Evaluate return of breast skin sensation at 12 months with mono-filament testing to compare sensory outcomes between techniques \[in MUMC+ only\].
Time frame: 12 months
Physical Function and Pain
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.
Time frame: 12 months
Breast Aesthetics & Volume
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.
Time frame: 12 months
Radiation-Associated Changes
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
Time frame: 12 months
Physical Well-being: Chest (BREAST-Q)
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.
Time frame: 12 months
Sexual Well-being (BREAST-Q)
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.
Time frame: 12 months
Breast Sensation (BREAST-Q)
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.
Time frame: 12 months
Donor Site Satisfaction (BODY-Q)
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.
Time frame: 12 months
Adverse Effects of Radiation (BREAST-Q)
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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2032, 72 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 72 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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