3D Printed Breast Models in the Surgical Management of Breast Cancer
2 other identifiers
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2024
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedStudy Start
First participant enrolled
February 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
ExpectedFebruary 27, 2026
February 1, 2026
2 years
February 20, 2023
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Decision Conflict Scale (DCS) score questionnaires
Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4
through study completion; an average of 1 year.
Study Arms (2)
Arm 1: 3D printed model
EXPERIMENTALa 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.
Arm 2: No 3D printed model
NO INTERVENTIONParticipants will have a standard-of-care surgical consultation using traditional breast imaging.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Chang Sen, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 6, 2023
Study Start
February 29, 2024
Primary Completion
February 28, 2026
Study Completion (Estimated)
February 28, 2028
Last Updated
February 27, 2026
Record last verified: 2026-02