Breast CancerNCT01756092
Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
A study testing Autologous Fat Graft in people with Breast Cancer and Lumpectomy, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Lumpectomy, Mastectomy, Segmental
- What is being tested?
- Autologous Fat Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Lumpectomy, Mastectomy, Segmental
- Being tested
- Autologous Fat Graft
- Keywords
- Breast Cancer, Lumpectomy, Mastectomy, Segmental
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat GraftProcedure or surgery
Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fat Graft | Experimental | Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity. Receives: Procedure: Autologous Fat Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 12 months following procedure
Secondary outcomes (1)
Patient Satisfaction
Measure patient satisfaction with use of quality of life questionnaires (SF-36 and BREAST-Q) before and after autologous fat grafting.
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Because funding was not secured, the study was never initiated. 0 subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756092
- Sponsor's protocol ID
- PRO10020385
- Status last verified
- Oct 2016
- First submitted
- 19 Dec 2012
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17415234Bircoll M, Novack BH. Autologous fat transplantation employing liposuction techniques. Ann Plast Surg. 1987 Apr;18(4):327-9. doi: 10.1097/00000637-198704000-00011.
PubMed 3579174Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.
PubMed 3725947Matsudo PK, Toledo LS. Experience of injected fat grafting. Aesthetic Plast Surg. 1988 Feb;12(1):35-8. doi: 10.1007/BF01570383.
PubMed 3376783Coleman SR. Facial augmentation with structural fat grafting. Clin Plast Surg. 2006 Oct;33(4):567-77. doi: 10.1016/j.cps.2006.09.002.
PubMed 17085224Ellenbogen 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.
PubMed 3273033Coleman 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.
PubMed 17312477Spear 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.
PubMed 16217471Marra 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.
PubMed 18349632Dudas 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.
PubMed 18362712De 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.
PubMed 12835573Rigotti, 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
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.
PubMed 20079699Delay 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.
PubMed 19825464Rigotti 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.
PubMed 20333521
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
- ClinicalTrials.gov ID
- NCT01756092
- Acronym / sponsor ID
- PRO10020385
- Conditions
- Breast Cancer, Lumpectomy, Mastectomy, Segmental
- Keywords
- Breast Cancer, Lumpectomy, Mastectomy, Segmental
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because funding was not secured, the study was never initiated. 0 subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Fat Graft | Experimental | Procedure: Autologous Fat GraftParticipants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Fat GraftParticipants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity. | Procedure or surgery | Autologous Fat Graft |
Primary outcome
Breast Tissue Volume/Appearance (Graft Retention)
Time frame: 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.
1 secondary outcome
Patient Satisfaction
Time frame: 6 months after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 17415234Rigotti 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.
- Background: PubMed 3579174Bircoll M, Novack BH. Autologous fat transplantation employing liposuction techniques. Ann Plast Surg. 1987 Apr;18(4):327-9. doi: 10.1097/00000637-198704000-00011.
- Background: PubMed 3725947Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.
- Background: PubMed 3376783Matsudo PK, Toledo LS. Experience of injected fat grafting. Aesthetic Plast Surg. 1988 Feb;12(1):35-8. doi: 10.1007/BF01570383.
- Background: PubMed 17085224Coleman SR. Facial augmentation with structural fat grafting. Clin Plast Surg. 2006 Oct;33(4):567-77. doi: 10.1016/j.cps.2006.09.002.
- Background: PubMed 3273033Ellenbogen 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.
- Background: PubMed 17312477Coleman 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.
- Background: PubMed 16217471Spear 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.
- Background: PubMed 18349632Marra 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.
- Background: PubMed 18362712Dudas 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.
- Background: PubMed 12835573De 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.
- BackgroundRigotti, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Peter Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fat Graft in people with Breast Cancer and Lumpectomy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Tissue Volume/Appearance (Graft Retention) (time frame: Through 12 months following procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756092, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.