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

Not Applicable

Withdrawn

• Conditions: Lumpectomy; Mastectomy, Segmental; Breast Cancer
• Interventions: Procedure: Autologous Fat Graft

• Registration Number: NCT01756092
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-24
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Fat Graft	Autologous Fat Graft	Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.

Primary Outcome Measures

Name	Time	Method
Breast Tissue Volume/Appearance (Graft Retention)	Through 12 months following procedure	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

Name	Time	Method
Patient Satisfaction	6 months after procedure	Measure patient satisfaction with use of quality of life questionnaires (SF-36 and BREAST-Q) before and after autologous fat grafting.

Trial Locations

Locations (1)

UPMC Center for Innovation in Restorative Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States