Autologous Fat Transfer for Breast Reconstruction

Recruiting at 1 trial location

Overseen By Fatima Merchant, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Active cancer, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 week

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Autologous Fat Transfer for Breast Reconstruction?

Research shows that autologous fat transfer is a safe and effective method for improving breast shape, volume, and symmetry after reconstruction. Patients often report significant improvements, although repeat procedures may be needed, especially for those who have had radiation therapy. ^{1 2 3 4 5}

Is autologous fat transfer for breast reconstruction safe?

Autologous fat transfer is generally considered safe for breast reconstruction, with studies showing it can be safely used after procedures like nipple-sparing mastectomy. However, there are concerns about its impact on cancer safety and follow-up, and while complications can occur, it is often seen as a reliable procedure when done correctly. ^{2 6 7 8 9}

How is autologous fat transfer unique for breast reconstruction?

Autologous fat transfer is unique because it uses the patient's own fat to reconstruct the breast, which can improve the breast's shape and contour naturally. This method is different from other treatments as it involves harvesting, processing, and reinjecting fat, offering a more natural alternative to implants. ^{1 6 10 11 12}

What is the purpose of this trial?

This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6.

Research Team

Summer Hanson, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults over 18 planning to have fat transferred from one part of their body to reconstruct the breast or chest wall. They must be able to give consent and undergo MRI scans.

Inclusion Criteria

Able to undergo MRI

Able to provide written or electronic informed consent

I am planning to have breast or chest wall reconstruction using my own fat.

Exclusion Criteria

Vulnerable subjects (children, prisoners, pregnant women)

Unable to undergo MRI (history of metal contraindication, claustrophobia)

I have active cancer, metastatic disease, or an autoimmune condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Participants meet with research staff for consent and undergo baseline imaging and data collection

1 week

1 visit (in-person)

Treatment

Participants undergo autologous fat transfer for breast or chest wall reconstruction

1 week

1 visit (in-person)

Follow-up

Participants undergo follow-up imaging and complete questionnaires to evaluate outcomes

1 year

4 visits (in-person)

Treatment Details

Interventions

• Autologous Fat Transfer

Trial Overview The study tests how well autologous fat transfer works for reconstruction by using MRI, ultrasound, and both 2-D and 3-D photos before and after the procedure. It also measures patient satisfaction through a questionnaire.

Participant Groups

Group I: Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall Experimental Treatment 5 Interventions

Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study.

Autologous Fat Transfer is already approved in European Union, United States for the following indications:

Approved in European Union as Autologous Fat Transfer for:

• Breast reconstruction after mastectomy
• Contour defects and fibrosis
• Thin tissue cover of the prosthesis
• Asymmetry in breast shape and/or volume
• Capsular contracture in implant reconstruction

Approved in United States as Autologous Fat Transfer for:

• Breast reconstruction after mastectomy
• Contour deformities
• Improving tissue quality after radiation therapy
• Post-mastectomy pain syndrome

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 53 breast reconstruction patients, autologous fat transplantation showed a complication rate of 7.4%, which is comparable to other studies, indicating a relatively safe procedure.

The technique involved careful fat harvesting and injection, with 28.3% of patients requiring repeat grafting due to fat resorption, highlighting the need for potential follow-up treatments to achieve desired results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous fat transplantation for secondary breast reconstruction: our experience. Simonacci, F., Grieco, MP., Bertozzi, N., et al.[2019]

Autologous fat transplantation is gaining popularity for reconstructing soft tissue defects after cancer surgery, showing promise as an effective and safe procedure when performed correctly.

Despite the lack of long-term randomized studies, the technique involves biologically active tissue that may raise oncological safety concerns, highlighting the need for careful patient monitoring and the establishment of national registries for follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autologous fat transplantation in the modern reconstructive surgery of breast cancer]. Mátrai, Z., Pesthy, P., Gulyás, G., et al.[2022]

Autologous fat grafting is a safe and effective method for improving breast contour, volume, and shape in secondary breast reconstruction, with an 83% improvement reported by patients after more than 6 months of follow-up.

Complications occurred in 11% of patients, with a higher incidence in those undergoing implant reconstructions, and repeat fat injections were needed in 25% of cases, especially among patients with a history of radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous fat grafting in secondary breast reconstruction. Losken, A., Pinell, XA., Sikoro, K., et al.[2022]

In a study of 40 post-radiation breast cancer patients, lipofilling significantly improved skin quality and reduced post-radiation skin scores from 2.40 to 1.21, indicating its efficacy in enhancing tissue quality after breast reconstruction.

The procedure was found to be safe with no recurrence of breast cancer among participants, suggesting that lipofilling is a viable option for addressing volume deficiencies and asymmetries in breast reconstruction, especially in patients with a history of radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipofilling effects after breast cancer surgery in post-radiation patients: an analysis of results and algorithm proposal. Debald, M., Pech, T., Kaiser, C., et al.[2020]

In a study of 110 patients who underwent autologous fat graft injections for breast reconstruction, 91.8% were alive and recurrence-free after a mean follow-up of 6.3 years, suggesting a favorable oncologic outcome.

The study indicates that lipofilling may have little to no effect on the risk of locoregional recurrence of breast cancer, although further research with larger, randomized trials is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oncologic outcome of 11.6 lipofilling procedures for reconstructive breast surgery]. Missana, MC., Germain, MA.[2019]

In a study of 267 patients undergoing autologous fat transfer for breast reconstruction, the centrifugation technique was linked to the highest rates of complications, including oil cysts (12.5%) and total complications (25.6%).

The Telfa gauze method showed the lowest complication rates (0% oil cysts, 2.3% total complications), while the Revolve technique had a significantly lower rate of repeated injections (5.45%) compared to centrifugation (19.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profiles of Fat Processing Techniques in Autologous Fat Transfer for Breast Reconstruction. Ruan, QZ., Rinkinen, JR., Doval, AF., et al.[2021]

Doppler-ultrasound (DUS) imaging was successfully used in a study of 20 female patients (average age 57.9 years) to safely guide the harvesting and injection of autologous fat for facial lipofilling, helping to visualize and avoid the temporal artery during the procedure.

The study reported only one case of edema and nodules, indicating a favorable safety profile for DUS-guided lipofilling, suggesting that DUS should be considered an essential part of the procedure to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. Kadouch, J., Schelke, LW., Swift, A.[2021]

A study of 72 patients who underwent delayed autologous fat grafting after breast conservation therapy found no difference in cancer recurrence rates compared to a matched control group, indicating that fat grafting does not compromise oncologic safety.

The research also showed no significant differences in complications such as fat necrosis, palpable masses, or abnormal radiographic findings, suggesting that autologous fat grafting does not interfere with oncologic surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic Safety and Surveillance of Autologous Fat Grafting following Breast Conservation Therapy. Hanson, SE., Kapur, SK., Garvey, PB., et al.[2023]

A study involving 117 breasts after nipple-sparing mastectomy demonstrated that autologous fat transfer can be safely performed in both smokers and patients who have undergone radiation, with comparable aesthetic outcomes across all groups.

Despite some differences in the number of fat transfer sessions and injected fat volumes, the overall aesthetic results were high for all groups, indicating the efficacy of the fat transfer protocol in achieving satisfactory breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical and Aesthetic Results of a Systematic Fat Transfer Protocol for Total Breast Reconstruction after Nipple-Sparing Mastectomy. Sorotos, M., Paolini, G., D'Orsi, G., et al.[2022]

Long-term follow-up of oil cysts from autologous fat grafting in three subjects revealed persistent chronic inflammation and progressive calcification over 2 to 6 years, indicating potential complications from improper fat grafting techniques.

Histopathological analysis showed that oil cysts contained inflammatory cells and significant structural changes, emphasizing the need for standardized injection techniques to minimize the risk of these adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic inflammation and progressive calcification as a result of fat necrosis: the worst outcome in fat grafting. Mineda, K., Kuno, S., Kato, H., et al.[2022]

In a study of 46 patients comparing three methods of preparing adipose grafts for breast reconstruction, no significant differences were found in postoperative complications, fat necrosis rates, or contour irregularity among the active filtration, passive filtration, and centrifugation techniques.

The study revealed that patients with a history of breast conservation treatment had a significantly higher risk of fat necrosis, regardless of the graft preparation method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized Comparison of Clinical Outcomes with Different Processing Techniques in Autologous Fat Grafting. Hanson, SE., Garvey, PB., Chang, EI., et al.[2022]

About two-thirds of specialists in gynecology and plastic surgery in Germany use autologous fat transfer for breast reconstruction, and they report no increase in local recurrence of cancer following the procedure.

The method is well-accepted by both patients and physicians, with high ratings for the improvement it provides, highlighting the need for further research, particularly in high-risk patients, to establish more robust data on its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Lipotransfer - Daily Therapeutic Practice in Breast Cancer: An Intergroup Analysis Encompassing NOGGO, WSG, GBG, AWO Gyn and DGPRÄC. Kümmel, A., Kümmel, S., Blohmer, JU., et al.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Autologous fat transplantation for secondary breast reconstruction: our experience. [2019]

2. Hungary pubmed.ncbi.nlm.nih.gov

[Autologous fat transplantation in the modern reconstructive surgery of breast cancer]. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Autologous fat grafting in secondary breast reconstruction. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Lipofilling effects after breast cancer surgery in post-radiation patients: an analysis of results and algorithm proposal. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Oncologic outcome of 11.6 lipofilling procedures for reconstructive breast surgery]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Profiles of Fat Processing Techniques in Autologous Fat Transfer for Breast Reconstruction. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Oncologic Safety and Surveillance of Autologous Fat Grafting following Breast Conservation Therapy. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Long-Term Clinical and Aesthetic Results of a Systematic Fat Transfer Protocol for Total Breast Reconstruction after Nipple-Sparing Mastectomy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Chronic inflammation and progressive calcification as a result of fat necrosis: the worst outcome in fat grafting. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized Comparison of Clinical Outcomes with Different Processing Techniques in Autologous Fat Grafting. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Autologous Lipotransfer - Daily Therapeutic Practice in Breast Cancer: An Intergroup Analysis Encompassing NOGGO, WSG, GBG, AWO Gyn and DGPRÄC. [2022]