Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
Completed
Conditions studied: Cancer of the Breast, Anomaly of Breast
In brief
The purpose of the study is to evaluate the safety and efficacy of breast reconstruction using Autologous Fat Grafting (AFG) for women post lumpectomy that have contour defects. The study hypothesis is that AFG has emerged as a less invasive alternative to breast reconstruction post mastectomy. AFG could be used to treat breast contour defects with much less invasive outpatient surgery, using the patient's own cells and tissues, which overall reduces risk.
Key facts
- Study ID
- NCT02302196
- Run by
- Kaiser Permanente
- People needed
- 27
- Starts
- 2015-09-01
- Expected to finish
- 2021-07-13
- Last updated by the study team
- 2021-08-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women
- Age 18 > y/o
- If patient has had lumpectomy and radiation, need to be at least 3 years out from completion of radiation
- Must be a Kaiser Permanente Northwest Member
You may not qualify if…
- Active smokers, cannot quit smoking for at least one month before and after procedures
- Patients who have such extensive skin scarring that elasticity is lost
- Patients who have little to no subcutaneous donor fat
- Patients with BIRAD's 3 or greater mammograms after treatment
- Patients with aggressive cancer for which cure is the goal (do not want to exclude patients that want palliative procedure) - inflammatory breast cancer
- Patients with triple negative cancer - ER -, PR -, Her2-neu -
- Patients with BRCA or CHEK-2 gene mutations or those with strong family history of breast cancer [more than 2 first degree relatives with breast cancer]
- Patients that have had a lumpectomy for breast cancer who have declined radiation therapy when it was recommended to reduce risk of local recurrence (should not exclude patients over 70 y/o who have elected to have lumpectomy and anti-estrogen therapy instead of lumpectomy and radiation)
- Oncoplastic reduction patients
- Comorbidities that preclude multiple procedures being done
- Pregnant women
Where it is running
- Kaiser Permanente NW Region, Sunnybrook Medical Office Building — Clackamas, Oregon, United States
Full record on ClinicalTrials.gov
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