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

NCT01756092 | Withdrawn DMC

• 1 other identifier: PRO10020385
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Lumpectomy; Mastectomy, Segmental

Keywords

Breast Cancer; Lumpectomy; Mastectomy, Segmental

Outcome Measures

Primary Outcomes (1)

• Breast Tissue Volume/Appearance (Graft Retention)

  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.

  Through 12 months following procedure

Secondary Outcomes (1)

• Patient Satisfaction

  6 months after procedure

Other Outcomes (1)

• Assess Cellular Properties of Graft

  Sample collected at time of procedure

Study Arms (1)

Autologous Fat Graft

EXPERIMENTAL

Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.

Procedure: Autologous Fat Graft

Interventions

Autologous Fat Graft PROCEDURE

Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.

Autologous Fat Graft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Center for Innovation in Restorative Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (16)

• Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71.

  PMID: 17415234 BACKGROUND

• Bircoll M, Novack BH. Autologous fat transplantation employing liposuction techniques. Ann Plast Surg. 1987 Apr;18(4):327-9. doi: 10.1097/00000637-198704000-00011.

  PMID: 3579174 BACKGROUND

• Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.

  PMID: 3725947 BACKGROUND

• Matsudo PK, Toledo LS. Experience of injected fat grafting. Aesthetic Plast Surg. 1988 Feb;12(1):35-8. doi: 10.1007/BF01570383.

  PMID: 3376783 BACKGROUND

• Coleman SR. Facial augmentation with structural fat grafting. Clin Plast Surg. 2006 Oct;33(4):567-77. doi: 10.1016/j.cps.2006.09.002.

  PMID: 17085224 BACKGROUND

• Ellenbogen R. Free autogenous pearl fat grafts in the face--a preliminary report of a rediscovered technique. Ann Plast Surg. 1986 Mar;16(3):179-94. doi: 10.1097/00000637-198603000-00001.

  PMID: 3273033 BACKGROUND

• Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.

  PMID: 17312477 BACKGROUND

• Spear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. doi: 10.1097/01.prs.0000181509.67319.cf.

  PMID: 16217471 BACKGROUND

• Marra KG, DeFail AJ, Clavijo-Alvarez JA, Badylak SF, Taieb A, Schipper B, Bennett J, Rubin JP. FGF-2 enhances vascularization for adipose tissue engineering. Plast Reconstr Surg. 2008 Apr;121(4):1153-1164. doi: 10.1097/01.prs.0000305517.93747.72.

  PMID: 18349632 BACKGROUND

• Dudas JR, Losee JE, Penascino VM, Smith DM, Cooper GM, Mooney MP, Jiang S, Rubin JP, Marra KG. Leporine-derived adipose precursor cells exhibit in vitro osteogenic potential. J Craniofac Surg. 2008 Mar;19(2):360-8. doi: 10.1097/SCS.0b013e318163e17b.

  PMID: 18362712 BACKGROUND

• De Ugarte DA, Morizono K, Elbarbary A, Alfonso Z, Zuk PA, Zhu M, Dragoo JL, Ashjian P, Thomas B, Benhaim P, Chen I, Fraser J, Hedrick MH. Comparison of multi-lineage cells from human adipose tissue and bone marrow. Cells Tissues Organs. 2003;174(3):101-9. doi: 10.1159/000071150.

  PMID: 12835573 BACKGROUND

• Rigotti, G. Oncologic Safety of Adipose Derived Stem Cell Grafts in the Treatment of Post-Lumpectomy Patients. Presented at the 88th Annual Meeting of the American Society of Plastic Surgeons

  BACKGROUND

• Sinna R, Delay E, Garson S, Delaporte T, Toussoun G. Breast fat grafting (lipomodelling) after extended latissimus dorsi flap breast reconstruction: a preliminary report of 200 consecutive cases. J Plast Reconstr Aesthet Surg. 2010 Nov;63(11):1769-77. doi: 10.1016/j.bjps.2009.12.002. Epub 2010 Jan 15.

  PMID: 20079699 BACKGROUND

• Delay E, Garson S, Tousson G, Sinna R. Fat injection to the breast: technique, results, and indications based on 880 procedures over 10 years. Aesthet Surg J. 2009 Sep-Oct;29(5):360-76. doi: 10.1016/j.asj.2009.08.010.

  PMID: 19825464 BACKGROUND

• Rigotti G, Marchi A, Stringhini P, Baroni G, Galie M, Molino AM, Mercanti A, Micciolo R, Sbarbati A. Determining the oncological risk of autologous lipoaspirate grafting for post-mastectomy breast reconstruction. Aesthetic Plast Surg. 2010 Aug;34(4):475-80. doi: 10.1007/s00266-010-9481-2. Epub 2010 Mar 24.

  PMID: 20333521 BACKGROUND

• Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.

  PMID: 19644246 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: July 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)