Kaiser Permanente NW Region, Sunnybrook Medical Office Building
Clackamas, Oregon, 97015, United States
NCT Number: NCT02302196
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.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Clackamas, Oregon, 97015, United States
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.
.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Retrospective chart review for women who have undergone standard breast reconstruction for lumpectomy.
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.
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
Kaiser Permanente
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05716542
Behavior, Breast Cancer
St Louis, Missouri, United States
View Trial DetailsNCT06595901
Behavior, Breast Cancer
St Louis, Missouri, United States
View Trial DetailsNCT00530868
Breast Cancer, Breast Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT02595372
Breast Diseases, Breast Neoplasms
Washington D.C., District of Columbia, United States
View Trial Details