NCT04261829 AFT: Introduction of a Full Breast Reconstructive Method
| NCT ID | NCT04261829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2020-12-09 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2020-12-09 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.
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
Contact & Investigator
Andrzej Piatkowski de Grzymala, MD, MSc
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT04261829 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04261829 currently recruiting?
Yes, NCT04261829 is actively recruiting participants. Contact the research team at sander.schop@mumc.nl for enrollment information.
Where is the NCT04261829 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Venlo, Netherlands, Amsterdam, Netherlands, Arnhem, Netherlands and 4 additional locations.
Who is sponsoring the NCT04261829 clinical trial?
NCT04261829 is sponsored by Maastricht University Medical Center. The principal investigator is Andrzej Piatkowski de Grzymala, MD, MSc at Maastricht University Medical Center. The trial plans to enroll 350 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.