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Trial record 3 of 73 for:    Fat Grafting

Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects

This study is currently recruiting participants.
Verified March 2017 by Kaiser Permanente
Sponsor:
ClinicalTrials.gov Identifier:
NCT02302196
First Posted: November 26, 2014
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaiser Permanente
  Purpose

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.


Condition Intervention
Cancer of the Breast Anomaly of Breast Procedure: Autologous Fat Grafting of the Breast Other: Control Arm

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kaiser Permanente Northwest members (women) who have undergone lumpectomy and radiation treatment.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302196


Contacts
Contact: Britta Torgrimson-Ojerio, RN, PhD 503-331-6017 Britta.N.Torgrimson-Ojerio@kpchr.org

Locations
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   
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Jennifer Murphy, MD Kaiser Permanente Northwest Region
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02302196     History of Changes
Other Study ID Numbers: KPNW Fat Grafting 001
First Submitted: November 24, 2014
First Posted: November 26, 2014
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases