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Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)

This study is not yet open for participant recruitment.
Verified January 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01756092
First received: December 19, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators will assess changes in breast appearance, graft retention and quality of life over one year in patients who have received direct autologous adipose tissue injection for the treatment of objectionable post-surgical breast deformities. These patients have undergone the resection of breast tissue to treat either benign or malignant breast disease.


Condition Intervention
Breast Cancer
Lumpectomy
Mastectomy, Segmental
 Procedure: Autologous Fat Graft

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Breast Tissue Volume/Appearance (Graft Retention) [ Time Frame: Through 12 months following procedure ] [ Designated as safety issue: No ]
    Assess breast appearance and soft tissue volume before and after autologous fat grafting utilizing 2D / 3D digital photography and a physician rating scale to determine graft retention through 12 months following fat grafting procedure.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 6 months after procedure ] [ Designated as safety issue: No ]
    Measure patient satisfaction with use of quality of life questionnaires (SF-36 and BREAST-Q) before and after autologous fat grafting.


Other Outcome Measures:
  • Assess Cellular Properties of Graft [ Time Frame: Sample collected at time of procedure ] [ Designated as safety issue: No ]

    Preadipocyte yield: The number of cells isolated per gram of adipose tissue will be determined using a hemacytometer.

    Preadipocyte Viability: Cell viability will be determined using the Live/Dead assay.

    Preadipocyte Proliferation: Cellular proliferation of preadipocytes will be assessed with the CyQUANT Cell Proliferation Assay Kit (Invitrogen, Carlsbad, CA) at 48 and 96 hours.

    Preadipocyte Differentiation: The assessment of the potential of the preadipocytes to differentiate into adipogenic cell types will be assessed



Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Fat Graft
Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.
 Procedure: Autologous Fat Graft
Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.

Detailed Description:

During the past decade there has been increased awareness of the potential of free adipose cell grafting to treat a variety of problems in both reconstructive and cosmetic plastic surgery. There have been encouraging reports describing the use of autologous fat grafts (fat tissue harvested by standard liposuction techniques in a given patient and then re-injected at another site) for treating breast deformities in the setting of benign and previously treated malignant breast problems.

There has been a corresponding large scale laboratory investigation effort into the potential of adipose derived stem cells (ADSC's) harvested during liposuction and induced to differentiate into various cell types in the mesenchymal cell line. The potential clinical utility of these cells in the treatment of patients who present with a breast deformity after segmental mastectomy (lumpectomy) and radiation therapy has been described, but not studied in rigorous prospective manner.

The investigators believe that the clinical use of these autologous fat cell grafts have unique advantages in the treatment of breast deformities. The technique is minimally invasive, easily repeated and is associated with minimal surgical morbidity (indeed it may have the advantage of improving the appearance of both the breast deformity and the area from which they are harvested), it typically displays a rapid recovery, a complication rate that is no greater (and probably less than ) established and currently used surgical treatment(s) of these breast problems, and is oncologically safe.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 through 70 years of age inclusive and able to provide informed consent and
  • Subject is 6 months post chemotherapy or radiation treatment and is scheduled for physician evaluation for a standard of care breast fat graft procedure.
  • Per PI's discretion is stable post-surgery or who has a benign breast deformity or post segmental breast deformity
  • Willing and able to comply with the study schema for research procedures.

Exclusion Criteria:

Age less than 18 years

  • Inability to provide informed consent
  • Active chemotherapy or radiation therapy treatment for cancer diagnosis
  • Not clinically stable to have a surgical intervention
  • Active infection anywhere in the body
  • Known coagulopathy
  • Pregnancy
  • Per the PI's discretion, subject is not a candidate for participation in this clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756092

Contacts
Contact: Peter W Adams, BS 412-864-2582 adamsp3@upmc.edu

Locations
United States, Pennsylvania
UPMC Center for Innovation in Restorative Medicine Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: J. Peter Rubin, MD            
Sub-Investigator: Peter W Adams, BS            
Sub-Investigator: Paul Afrooz, MD            
Sub-Investigator: Autumn Aul, PA-C            
Sub-Investigator: Jacqueline Bliley            
Sub-Investigator: Spencer Brown, PhD            
Sub-Investigator: Carolyn De La Cruz, MD            
Sub-Investigator: Carlynn Jackson, BS, CCRC            
Sub-Investigator: Louise Martin, RN, BSN, CCRC            
Sub-Investigator: Nancy McCormick, MS, CCRC            
Sub-Investigator: Jenelle Mock, RN, BSN            
Sub-Investigator: Kenneth Shestak, MD            
Sub-Investigator: Patsy Simon, RN, BS, CCRC            
Sub-Investigator: Kelly Snyder, PA-C            
Sub-Investigator: Wendy Wakefield, CRNP            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J. Peter Rubin, MD University of Pittsburgh
  More Information

Publications:
Sinna, R., Delay, E., Garson, S., et al. Breast fat grafting (lipomodelling) after extended latissimus dorsiflap breast reconstruction: A preliminary report of 200 consecutive cases. Journal of Plastic, Reconstructive &Aesthetic Surgery 63: 1769-77, 2008.

Responsible Party: J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01756092     History of Changes
Other Study ID Numbers: PRO10020385
Study First Received: December 19, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Breast Cancer
Lumpectomy
Mastectomy, Segmental

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

ClinicalTrials.gov processed this record on May 21, 2013