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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve breast reconstruction after a mastectomy by using personalized 3D printed molds, known as "Breast Mold," to shape the tissue and make the process more efficient. Participants will be randomly assigned to receive either the 3D printed breast mold or the standard reconstruction method to compare outcomes. This trial suits patients scheduled for breast reconstruction using tissue from their own body, specifically with the DIEP or TRAM flap technique. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future reconstruction techniques.

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 prior data suggests that this breast mold is safe for post-mastectomy reconstruction?

Research has shown that 3D-printed breast molds used in reconstruction surgeries are generally safe. Studies have found that these molds, made from materials that naturally break down in the body, are well-tolerated during surgeries. They assist surgeons in shaping tissues effectively, leading to natural-looking results.

For example, studies report that patients who used 3D-printed molds for partial breast reconstruction achieved balanced and attractive outcomes. These molds also help surgeons better visualize the results, making the surgery more precise and customized to each individual.

So far, no major reports of negative effects have emerged from using these 3D-printed molds in surgeries. This suggests they are a safe option for those considering breast reconstruction using their own tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3D printed breast molds for post-mastectomy reconstruction because they offer a personalized approach to breast reconstruction. Unlike traditional methods that often rely on implants or tissue flaps, 3D printing allows for the creation of molds that match the unique anatomy of each patient. This technique has the potential to improve aesthetic outcomes and reduce the need for multiple surgeries. By tailoring the mold to each individual, the process could enhance patient satisfaction and recovery times.

What evidence suggests that breast molds are effective for post-mastectomy reconstruction?

This trial will compare 3D-printed breast molds with standard reconstruction methods for post-mastectomy patients. Research has shown that 3D-printed breast molds can significantly enhance breast reconstruction after a mastectomy. Studies have found that these molds allow surgeons to view the patient's body more clearly and plan the surgery with greater precision. This results in more accurate breast shaping, leading to outcomes that better align with patient expectations. Additionally, 3D printing addresses common issues like size and shape. Overall, this technology aims to improve the quality of life and emotional well-being for those undergoing breast reconstruction. ^{2 4 6 7 8}

Who Is on the Research Team?

Ashleigh M Francis, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

Patients who are willing and able to provide informed consent

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172985/

Three-Dimensional Printing in Breast Reconstruction Three-dimensional (3D) printing is dramatically improving breast reconstruction by offering customized and precise interventions at various stages of the ...

2. oaepublish.com oaepublish.com/articles/2347-9264.2024.56

A systematic review of 3D printing in autologous breast ... Surgeons can visualize potential outcomes more realistically through 3DP models of patient anatomy and determine viable autologous graft ...

3. mdpi.com mdpi.com/2077-0383/14/19/6737

State of Research on Tissue Engineering with 3D Printing ... Background: Three-dimensional (3-D) printing paired with tissue-engineering strategies promises to overcome the volume, contour, and donor-site limitations ...

4. threedmedprint.biomedcentral.com threedmedprint.biomedcentral.com/articles/10.1186/s41205-021-00095-8

Applications of 3D printing in breast cancer management Women who undergo breast reconstruction after mastectomy experience better psychosocial adjustment and quality of life than women who receive ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06993714

NCT06993714 | 3D-printed Biodegradable Breast Implants ... The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03348293

NCT03348293 | Safety Study of 3D Printing Personalized ... During operation, the biodegradable scaffold was implanted into the defective cavity after tumor resection. Safety indicator, cosmetic outcome and autologous ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e23227

A novel 3D-printed scaffold for patient-specific partial ... Patients who received partial breast reconstruction with 3D-printed scaffolds have natural-looking and symmetrical breasts after surgery.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06993714/3d-printed-biodegradable-breast-implants-for-breast-restoration

3D-printed Biodegradable Breast Implants for ... The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material ...