Evaluating a new method for breast reconstruction using fat transfer

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

This study is testing a new way to rebuild breasts using fat from the patient's own body after a mastectomy to see if it improves recovery and results compared to other methods.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Maastricht University Medical Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 8 sites (Maastricht, Limburg and 7 other locations)
• Trial ID: NCT04261829 on ClinicalTrials.gov

What this trial studies

This multicentre prospective cohort study aims to monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion in patients undergoing breast reconstruction after mastectomy. The study will assess various outcomes including quality of life, aesthetic results, complications, oncological safety, and cost-effectiveness. All participants will receive AFT, following insights gained from the previous BREAST trial that compared AFT with implant-based reconstruction. The study seeks to provide comprehensive data on this reconstructive method.

Who should consider this trial

Good fit: Ideal candidates include females aged 18 and older who are scheduled for a mastectomy and wish to participate in a breast reconstruction study.

Not a fit: Patients who are active smokers, have certain medical conditions, or have undergone recent chemotherapy or radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life and aesthetic outcomes for patients undergoing breast reconstruction.

How similar studies have performed: Previous studies have shown promise in using Autologous Fat Transfer for breast reconstruction, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Female gender
* Age of 18 years and older
* History or in candidate for a mastectomy procedure in the near future
* Patients undergoing preventive mastectomy
* Patients' choice to undergo a breast reconstruction
* Wanting to participate in this study
* Patient is able to wear the external expansion device

Exclusion Criteria:

* Active smoker or a history of smoking 4 weeks prior to surgery
* Current substance abuse
* History of lidocaine allergy
* History of silicone allergy
* 4 weeks or less after chemotherapy
* History of radiation therapy in the breast region
* Oncological treatment includes radiotherapy after mastectomy
* Kidney disease
* Steroid dependent asthma (daily or weekly) or other diseases
* Immune-suppressed or compromised disease
* Uncontrolled diabetes
* BMI\>30
* Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
* Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
* The treating plastic surgeon has strong doubts on the patient's treatment compliance

Where this trial is running

Maastricht, Limburg and 7 other locations

• Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (ENROLLING_BY_INVITATION)
• Viecuri Venlo — Venlo, Limburg, Netherlands (RECRUITING)
• Amsterdam University Medical Center (VUMC) — Amsterdam, Netherlands (ENROLLING_BY_INVITATION)
• Rijnstate — Arnhem, Netherlands (ENROLLING_BY_INVITATION)
• Alexander Monro, Bilthoven — Bilthoven, Netherlands (ENROLLING_BY_INVITATION)
• Amphia — Breda, Netherlands (ENROLLING_BY_INVITATION)
• Ziekenhuis groep Twente (ZGT) — Hengelo, Netherlands (RECRUITING)
• Medical Center Leeuwarden — Leeuwarden, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Andrzej Piatkowski de Grzymala, MD, MSc — Maastricht University Medical Center
• Study coordinator: Jamilla Wederfoort, MD, MSc

Conditions: Breast Cancer, Reconstructive Surgery, Breast Reconstruction