3D Printed Models for Breast Cancer Surgery Planning

Overseen By Lauren Chang Sen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breastfeeding, Mastectomy, others

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 3D printed model of the breast can help breast cancer patients make more informed surgical decisions. Participants will be divided into two groups: one will use the 3D model during their surgical consultation, while the other will rely on traditional imaging scans. Women diagnosed with breast cancer, considering surgery, and who have undergone an MRI for disease assessment might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative decision-making tools in breast cancer care.

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 seems focused on using 3D models for surgery planning, so it's unlikely to require changes to your medication.

What prior data suggests that the 3D printed model is safe for breast cancer surgery planning?

Research has shown that 3D printed models are safe for planning breast cancer treatments. Created using MRI scan data, these models help doctors plan surgeries with greater accuracy. Studies have found that they enhance communication between patients and doctors by providing a clear visual guide. This clarity helps patients understand the surgery process and make informed decisions.

No reports of negative effects have emerged from using these models. As tools for better visualization and planning, rather than treatments that enter the body, they are considered safe and well-tolerated by patients in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3D printed models for breast cancer surgery planning because they offer a personalized and tangible way to visualize tumors. Unlike traditional imaging techniques, which can be flat and hard to interpret, these 3D models allow surgeons and patients to hold and examine a life-sized replica of the breast, enhancing understanding and planning. This innovative approach could lead to more precise surgeries, potentially improving outcomes and reducing the likelihood of follow-up procedures.

What evidence suggests that a 3D printed model is effective for breast cancer surgery planning?

Research has shown that 3D printed breast models can significantly aid breast cancer patients in understanding their diagnosis and treatment options. In this trial, participants in one arm will receive a 3D printed model of their breast, which will be discussed during their surgical consultation. Studies have found that these models can increase patients' confidence and knowledge when selecting their treatment. The 3D models provide detailed information about the tumor's shape and location, enhancing surgical planning. They have improved surgeons' ability to accurately target tumors, potentially leading to more precise surgeries. Overall, these models offer a promising tool for better communication and decision-making in breast cancer care. ^{3 4 5 6 7}

Who Is on the Research Team?

Lauren Chang Sen, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18 or older with confirmed breast cancer, who are candidates for surgery and have had a breast MRI at MDACC. They must be willing to potentially receive either a 3D printed model of their breast or traditional imaging scans and consent to the study's process.

Inclusion Criteria

Patient is able to speak, read or write English

Patient is willing to be randomized to the control or 3D printed breast model groups and is willing to sign the consent form.

I am a woman aged 18 or older.

Exclusion Criteria

I had a mastectomy and my cancer has come back on the same side.

Pregnant and breastfeeding patients

It's not possible to make a 3D printed model of your breast using a breast MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation

Participants receive either a 3D printed model or traditional imaging during their surgical consultation

1 visit

1 visit (in-person)

Surgical Decision-making

Participants make decisions regarding their surgical options (mastectomy vs. lumpectomy) after viewing the models or imaging

2-4 weeks

Follow-up

Participants are monitored for satisfaction, well-being, and surgical outcomes post-surgery

1 year

What Are the Treatments Tested in This Trial?

Interventions

• 3D printed model

Trial Overview The study is testing whether providing patients with a 3D printed model of their breast helps in making decisions about their care compared to those who only receive traditional imaging scans. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Arm 1: 3D printed model Experimental Treatment 1 Intervention

a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.

Group II: Arm 2: No 3D printed model Active Control 1 Intervention

Participants will have a standard-of-care surgical consultation using traditional breast imaging.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer Center

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

Three-dimensional (3D) printing and tissue engineering are revolutionizing cancer research by creating advanced models that mimic the tumor microenvironment, which helps in understanding how cancer cells interact and respond to treatments.

These 3D-engineered scaffolds are being explored as personalized drug delivery systems, potentially leading to more effective cancer therapies by integrating insights from cancer biology and patient-specific data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Fabrication of Three-Dimensional Printed Scaffolds for Cancer Precision Medicine. Shafiee, A.[2021]

A 3D-printed breast cancer model was successfully developed to study the interactions between cancer cells and adipose tissue, highlighting the importance of the tumor microenvironment in cancer progression.

The model demonstrated that breast cancer cells can alter the adipose tissue by reducing lipid content and remodeling the extracellular matrix, which is crucial for understanding tumor-stroma interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioprinting and Differentiation of Adipose-Derived Stromal Cell Spheroids for a 3D Breast Cancer-Adipose Tissue Model. Horder, H., Guaza Lasheras, M., Grummel, N., et al.[2021]

3D printed models significantly enhance pre-operative planning for complex orthopedic surgeries by accurately representing tumor geometry and surrounding anatomy, leading to reduced operative time and blood loss.

In a study involving four complicated cases, these models helped orthopedic surgeons create personalized surgical plans, ultimately improving the selection of prosthetic devices and surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using 3D models in orthopedic oncology: presenting personalized advantages in surgical planning and intraoperative outcomes. Punyaratabandhu, T., Liacouras, PC., Pairojboriboon, S.[2020]

3D printed breast tumor models can significantly enhance patient understanding of their breast cancer diagnosis and treatment options, leading to better communication with healthcare teams.

These models not only aid in personalized treatment planning by visualizing patient-specific pathology but also serve as valuable educational tools for medical trainees involved in breast cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D printed model for triple negative inflammatory breast cancer. Huang, YH., Tuttle, TM., Hoven, N.[2022]

The use of patient-specific 3D models in midfacial distraction surgery significantly reduced complications, with no complications reported in the group that utilized the models compared to six complications in the group that did not.

3D models also decreased operative time by an average of 31.3 minutes, leading to estimated cost savings of $1036, highlighting their potential to improve surgical efficiency and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Benefit Analysis of Three-Dimensional Craniofacial Models for Midfacial Distraction: A Pilot Study. Rogers-Vizena, CR., Sporn, SF., Daniels, KM., et al.[2022]

The use of 3D printed liver models significantly enhanced parental understanding of liver anatomy, physiology, and surgical procedures in children with hepatic tumors, with improvements ranging from 21.4% to 31.4% across various topics.

This study involved 7 children and their 14 parents, demonstrating that personalized 3D models can effectively aid in patient education and preparation for surgery, leading to better-informed consent and expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of using three-dimensional printed liver models for patient education. Yang, T., Tan, T., Yang, J., et al.[2020]

In a case series involving five patients, 3D printing of breast cancer tumors was successfully achieved using data from MRI, digital breast tomosynthesis, and 3D ultrasound, demonstrating the feasibility of this technology in clinical practice.

The tumor volumes calculated from different imaging methods were comparable, suggesting that 3D printed models can accurately represent the spatial characteristics of tumors, which may aid surgeons in planning treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semi-automated delineation of breast cancer tumors and subsequent materialization using three-dimensional printing (rapid prototyping). Schulz-Wendtland, R., Harz, M., Meier-Meitinger, M., et al.[2017]

3-D printing significantly enhances patient-specific surgery planning by saving up to two-thirds of the time typically required, leading to improved surgical outcomes and accuracy.

The use of 3-D printed models is recommended as a standard protocol in various surgical fields, including orthopedic and craniofacial surgery, due to their ability to help visualize complex anatomy and improve overall surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Surgery Planning Using 3-D Printing: a Case Study. Singhal, AJ., Shetty, V., Bhagavan, KR., et al.[2022]

Creating a patient-specific 3D printed model of a breast cancer patient helped in visualizing the extent of the disease, which initially suggested a mastectomy was necessary.

Ultimately, the 3D model facilitated a decision for breast-conserving surgery, indicating that such models can improve patient understanding and potentially lead to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of three-dimensional printing in the surgical management of breast cancer. Santiago, L., Adrada, BE., Caudle, AS., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8011310/

Acceptability of 3D printed breast models and their impact ... To evaluate the acceptability and impact of 3D printed breast models (3D-BM) on treatment-related decisional conflict (DC) of breast cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11616315/

Development and evaluation of 3D-printed tumor palpation ... In this study, we developed 3D-printed palpation models for breast tumor detection and surveyed seven surgeons specializing in breast care to evaluate the ...

3. withpower.com withpower.com/trial/phase-2-breast-neoplasms-6-2023-23146

3D Printed Models for Breast Cancer Surgery Planning 3D printed breast tumor models can significantly enhance patient understanding of their breast cancer diagnosis and treatment options, leading to better ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010482521005783

Accuracy evaluation of a 3D printing surgical guide for ... This 3DP-BSG exhibits high accuracy in tumor targeting and is expected to facilitate precise BCS by providing a quantitative measure of the tumor area to ...

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

Applications of 3D printing in breast cancer management With 3D printing, tumor localization can be optimized as finite information can be provided regarding tumor morphology, shape, and location.

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

NCT03348293 | Safety Study of 3D Printing Personalized ... Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, the investigators created the personalized porous ...

7. 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 ...