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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05755984
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Study Start: 2024-02-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18 or older female
• Patient must have histologically confirmed breast malignancy
• Patient is a candidate for surgical management
• Patient has a surgeon at MDACC (main campus and/or Houston Area Locations)
• Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations).
• 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.

Exclusion Criteria

• Pregnant and breastfeeding patients
• Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side
• Patients for whom it is not feasible to create a 3D printed breast model from breast MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Decision Conflict Scale (DCS) score questionnaires	through study completion; an average of 1 year.	Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States