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

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

What data supports the effectiveness of the treatment 3D printed models for breast cancer surgery planning?

Research shows that using 3D printed models for breast cancer surgery can help patients and doctors make better decisions about surgery options, improve understanding of the disease, and enhance communication, which can lead to better surgical outcomes. ^{1 2 3 4 5}

Is it safe to use 3D printed models for breast cancer surgery planning?

The available research does not specifically address the safety of 3D printed models for breast cancer surgery planning, but these models are used to help patients and doctors understand the surgery better, which can improve decision-making and planning. ^{1 2 6 7 8}

How does the 3D printed model treatment for breast cancer surgery planning differ from other treatments?

The 3D printed model treatment for breast cancer surgery planning is unique because it uses personalized, three-dimensional models to help patients and surgeons visualize the tumor and surrounding anatomy, improving decision-making and surgical planning. This approach enhances patient understanding and communication with the healthcare team, potentially leading to better surgical outcomes and reduced decision conflict compared to traditional methods that rely solely on imaging reports. ^{1 2 3 4 9}

What is the purpose of this trial?

To learn if providing a 3-D printed model of the breast can help breast cancer patients make decisions related to their care. During this study, some study participants will receive the 3-D printed model and some study participants will receive traditional breast imaging scans to learn if the 3-D printed model

Research Team

Lauren Chang Sen, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

The role of three-dimensional printing in the surgical management of breast cancer. [2020]

2. England pubmed.ncbi.nlm.nih.gov

3D printed model for triple negative inflammatory breast cancer. [2022]

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

Semi-automated delineation of breast cancer tumors and subsequent materialization using three-dimensional printing (rapid prototyping). [2017]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Using 3D models in orthopedic oncology: presenting personalized advantages in surgical planning and intraoperative outcomes. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The impact of using three-dimensional printed liver models for patient education. [2020]

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

Cost-Benefit Analysis of Three-Dimensional Craniofacial Models for Midfacial Distraction: A Pilot Study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Bioprinting and Differentiation of Adipose-Derived Stromal Cell Spheroids for a 3D Breast Cancer-Adipose Tissue Model. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Improved Surgery Planning Using 3-D Printing: a Case Study. [2022]