Breast Molds for Post-Mastectomy Reconstruction

Overseen By Ashleigh M Francis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Stacked flaps, Lymph node transfer, Radiation

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative

160 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Breast Mold for post-mastectomy reconstruction?

Research suggests that using 3D printed breast molds can improve the shaping of reconstructed breasts after mastectomy, as they help form the breast more easily during surgery. Additionally, using a bioabsorbable mold can help maintain the shape of the breast during healing, potentially leading to better outcomes. ^{1 2 3 4 5}

Is the use of breast molds for post-mastectomy reconstruction generally safe?

Breast reconstruction using implants, including silicone, is generally considered safe, though there are risks like capsular contracture (tightening of scar tissue around the implant) and implant rupture. Acellular dermal matrix (ADM) used in reconstruction has been associated with slightly higher rates of infection and reoperation compared to non-ADM methods. ^{6 7 8 9 10}

How does the Breast Mold treatment differ from other post-mastectomy reconstruction treatments?

The Breast Mold treatment is unique because it uses a temporary, low-cost, disposable mold made from Silastic rubber or 3D printed materials to help shape the breast during surgery. This approach allows for a more tailored and precise reconstruction compared to traditional methods, which may not use such specific molds. ^{1 2 3 5 11}

What is the purpose of this trial?

The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.

Research Team

Ashleigh M Francis, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals who have undergone a mastectomy and are planning to have autologous breast reconstruction. Specific details about eligibility criteria were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

I am scheduled for breast reconstruction using tissue from my belly.

Patients who are willing and able to provide informed consent

Exclusion Criteria

I am receiving radiation before surgery.

My surgery plan includes using tissue from my thigh or buttock for breast reconstruction.

My surgery plan includes DIEP flap and lymph node transfer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo autologous breast reconstruction using 3D-printed participant-specific molds or standard of care reconstruction

Intraoperative

Follow-up

Participants are monitored for safety and effectiveness after reconstruction, including assessment of adverse events and complications

1 year

Treatment Details

Interventions

• Breast Mold

Trial Overview The study is testing the use of patient-specific molds designed with clinical decision-support algorithms during autologous breast reconstruction surgery after mastectomy. The aim is to see if these molds improve the efficiency and outcomes of creating a natural breast shape.

Participant Groups

Group I: Standard of Care Reconstruction Experimental Treatment 1 Intervention

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Group II: Intraoperative Use of 3D Printed Breast Mold Experimental Treatment 1 Intervention

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Applications and limitations of using patient-specific 3D printed molds in autologous breast reconstruction. [2022]

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

Shaping a Flap Using a Bioabsorbable Mold-A Preliminary Report. [2022]

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

The use of an intraoperative molding device for the reconstruction of a female breast after mastectomy. [2015]

4. England pubmed.ncbi.nlm.nih.gov

The use of tissue expanders in immediate breast reconstruction following mastectomy for cancer. [2019]

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

[Initial results of immediate reconstruction of the breast following mastectomy]. [2010]

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

The political and social context of silicone breast implant use in the United States. [2005]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Analysis Evaluating the Safety of Using Acellular Dermal Matrix with Tissue Expander-Based Breast Reconstruction. [2022]

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

Breast Reconstruction. [2018]

9. Hungary pubmed.ncbi.nlm.nih.gov

[Oncologic safety of skin-sparing mastectomy followed by immediate breast reconstruction: rate and localization of recurrences, and impact of reconstruction techniques]. [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Tertiary Autologous Breast Reconstruction After Implant-Based Reconstruction: Safety and Patient-Related Outcomes. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Immediate breast reconstruction after mastectomy for cancer. [2022]