NCT05755984

3D Printed Breast Models in the Surgical Management of Breast Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary Objective: •The objective of this prospective study is to determine the impact of 3D printed breast models, compared to 2D imaging, on breast cancer patients' decisional conflict related to treatment decision-making. Secondary Objective: * To observe if patients will change their initial desired surgical option (mastectomy versus lumpectomy) after viewing the 3D printed models * To evaluate the quality of the communication between surgical providers and patients with and without the 3D printed models * To assess the surgical outcome including the margin status * To evaluate patient satisfaction and well-being post-surgery between the 3D printed model group and the control group as well as mastectomy versus lumpectomy subgroups * To assess surgical providers' response to the acceptability and utility of the model

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	3D printed model	scan

Timeline

• Start date: 2024-02-29
• Primary completion: 2026-02-28
• Completion: 2028-02-28
• First posted: 2023-03-06
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States