3D-Printed Prosthesis for Breast Cancer

Overseen By Nicole G. Sanchez Figueroa, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Severe medical conditions, others

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

Compensation: Varies

Number of Visits: 7

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine if a 3D-printed breast prosthesis provides a more comfortable and better-fitting option for breast cancer patients who have undergone a mastectomy without reconstruction. The researchers aim to assess whether this customized prosthesis, created using 3D imaging and design, can enhance patients' comfort and quality of life. It suits those who have had a mastectomy, did not receive breast reconstruction, and are open to trying a new type of prosthesis. As an unphased trial, this study offers patients a unique opportunity to explore innovative solutions that could improve their comfort and quality of life.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a 3D-printed breast prosthesis, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that this 3D-printed external breast prosthesis is safe?

Previous studies have shown that patients have well-received 3D-printed external breast prostheses. Custom-made to fit each person, these prostheses can improve comfort and satisfaction. Research indicates that 3D printing results in more comfortable and better-fitting prostheses compared to traditional ones. No major problems or safety issues have been reported with these 3D-printed prostheses, making them a promising option for those considering them after mastectomy (breast removal surgery). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D-printed external breast prostheses because they offer a personalized and potentially more comfortable alternative to traditional prosthetics. Unlike standard prostheses that come in predefined sizes and shapes, these are custom-designed using computer-aided design (CAD) and 3D printing technology, ensuring a perfect fit for each individual. This innovative approach not only enhances comfort and appearance but also has the potential to improve the psychological well-being of breast cancer patients by providing a more natural look and feel.

What evidence suggests that this 3D-printed prosthesis is effective for breast cancer patients?

Studies have shown that 3D-printed external breast prostheses greatly improve comfort and fit compared to traditional options. In this trial, participants will receive a 3D-printed external breast prosthesis, crafted specifically for each patient using 3D imaging and computer design to ensure a better fit. This personalized approach can lead to higher satisfaction and improved experiences for breast cancer patients who have undergone a mastectomy. Initial findings suggest that 3D printing offers a more tailored and potentially more affordable option for those who choose not to undergo surgical reconstruction. Overall, early evidence indicates that this innovative method positively impacts the quality of life for these patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Aparna Vijayasekaran, MBBS

Principal Investigator

Mayo Clinic

Sandhya Pruthi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who have had a mastectomy without reconstruction. It's designed to see if using a custom-made, 3D-printed external breast prosthesis can improve their quality of life.

Inclusion Criteria

Ability to provide informed consent

Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses

I am 18 years old or older.

Exclusion Criteria

Inability to communicate effectively in the study language (e.g., English)

Individuals with contraindications for participation, such as severe medical conditions that may interfere with study procedures

I am unable or unwilling to give consent for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Fitting and Prosthesis Development

Participants undergo CT, development of a patient-specific external breast prosthesis model using CAD, and measurements for 3D-printed external breast prosthesis

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for patient-reported outcomes including comfort, fit, satisfaction, and emotional well-being

1 year

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 3D-Printed External Breast Prosthesis

Trial Overview The study tests whether a personalized, 3D-printed breast prosthesis offers better comfort and fit compared to traditional prostheses. Patients' experiences with the new prosthesis are measured through questionnaires.

How Is the Trial Designed?

Group I: Supportive care (3D-printed external breast prosthesis) Experimental Treatment 3 Interventions

Patients undergo CT, development of a patient-specific external breast prosthesis model using CAD, and measurements for 3D-printed external breast prosthesis during screening. Patients then undergo fitting for and receive the 3D-printed external breast prosthesis on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. mayo.edu mayo.edu/research/clinical-trials/cls-20576355

3D-Printed Individualized External Breast Prostheses ... This study aims to evaluate the efficacy of personalized 3D-printed external breast prostheses for patients opting out of reconstruction and assess their ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003323002541

Development of low-cost and personalized external ... The aim of this study was to develop a low-cost and personalized method for external breast prosthesis production.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07047872

NCT07047872 | A 3D-Printed External Breast Prosthesis ... This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among ...

4. 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 ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9394292/

3D and 4D Printing in the Fight against Breast Cancer - PMC This review article provides an overview of current approaches for breast cancer management, including standard treatments and breast reconstruction strategies.

7. biomedgrid.com biomedgrid.com/fulltext/volume22/fully-automated-ultra-personalized-3d-printed-prosthetic-breasts.002935.php

Fully Automated Ultra-Personalized 3D Printed Prosthetic ... For example, in Brazil, breast neoplasms were responsible for the highest number of new cases among women in 2020, reaching 29.7% (66,280 cases) ...