Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
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.
|Cancer of the Breast Anomaly of Breast||Procedure: Autologous Fat Grafting of the Breast Other: Control Arm|
|Study Design:||Observational Model: Case-Control
Time Perspective: Prospective
|Official Title:||Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects|
- Safety of Autologous Fat Grafting (AFG) compared to standard breast reconstruction for lumpectomy, as measured by the BIRADS scores [ Time Frame: 5 years for lumpectomy ]The experimental AFG group will have the same or less change in the BIRADS scores than the control non-AFG group.
- Women undergoing Autologous Fat (AFG) Grafting of the breast [ Time Frame: Prior to AFG and 1 year after procedure ]The Breast Q survey will be administered to women before and after the AFG procedure
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||January 2022|
|Estimated Primary Completion Date:||January 2022 (Final data collection date for primary outcome measure)|
Autologous Fat Grafting of the breast
Approximately 100 women who have had a lumpectomy and qualify, will be offered Autologous Fat Grafting (AFG) procedure. Patients will be assessed 3 months post grafting for safety and efficacy by Breast-Q survey, mammography BIRADS scoring and physical assessment. The AFG may be repeated x 2 at a 3-6 month interval if deemed necessary by the treating surgeon, then reassessed again 3 months later in the same way. Repeat mammogram will be done 1 year post AFG.
Procedure: Autologous Fat Grafting of the Breast
In fat grafting, fat tissue is removed from other parts of the body; usually thighs, belly, and buttocks by liposuction. The tissue is then processed and injected into the breast area to reconstruct or recreate the breast. The fat will be removed from by a narrow surgical instrument (cannula) through a small incision. Then the fat will be prepared in a specific way before being replaced back in the body. This preparation may include washing, filtering, and centrifugation (spinning) of the fat. The fat is then placed into the desired area of the breast using either a smaller cannula or needle.
Control arm standard treatment
Retrospective chart review will be done in 100 women who have undergone standard treatment for breast contour defect after lumpectomy.The control group will be measured by compiling BIRADS scores as well as frequency of subsequent surgical intervention (as necessitated by increased BIRADS scores or by new physical findings on exam) over a 5 year period post lumpectomy.
Other: Control Arm
Retrospective chart review for women who have undergone standard breast reconstruction for lumpectomy.
About 200 women at Kaiser Permanente Northwest will be in this study. The study will include about 100 women who have had a lumpectomy and consent to be in the research arm and have AFG and 100 from the control arm (retrospective chart review).
Autologous Fat Grafting Arm: Breast-Q survey of patient satisfaction will be collected before and after AFG. Assessments will be done 3 months post grafting for efficacy (excellent 100% correction of defect), good (75% correction of defect), fair (50% correction of defect), poor 25% or less correction of defect) result will be recorded. AFG may be repeated x 2 at a 3-6 month interval if deemed necessary by the treating surgeon, then reassessed again 3 months later in the same way. A mammographic assessment of the breast, scored by radiologist in a 6 step scoring system (BIRADS score) will be done 1 year after AFG. BIRADS scores and new physical finding will continue to be collected for a 5 year period post AFG post lumpectomy group.
Control (non-Autologous Fat Grafting) arm: Retrospective chart review for women who have undergone standard treatment to treatment to reconstruct their breasts. Data collected will include; BIRADS scores as well as frequency of subsequent surgical intervention (as necessitated by increased BIRADS scores or by new physical findings on exam) over a 5 year period post lumpectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02302196
|Contact: Britta Torgrimson-Ojerio, RN, PhD||503-331-6017||Britta.N.Torgrimson-Ojerio@kpchr.org|
|United States, Oregon|
|Kaiser Permanente NW Region, Sunnybrook Medical Office Building||Recruiting|
|Clackamas, Oregon, United States, 97015|
|Contact: Britta Torgrimson-Ojerio, RN, PhD 503-331-6017 Britta.N.Torgrimson-Ojerio@kpchr.org|
|Principal Investigator:||Jennifer Murphy, MD||Kaiser Permanente Northwest Region|