3D Printed Breast Models in the Surgical Management of Br... | NCT05755984

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

NCT05755984

Sponsor

M.D. Anderson Cancer Center

Status

Active, not recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

3D printed model

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2023-01852	Other Identifier	NCI-CTRP Clinical Trials Registry

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 29, 2024Actual

Primary Completion Date

Feb 28, 2026Estimated

Completion Date

Feb 28, 2028Estimated

First Submitted Date

Feb 20, 2023

First Submission Date that Met QC Criteria

Feb 23, 2023

First Posted Date

Mar 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2026

Last Update Posted Date

Feb 27, 2026Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: 3D printed model	Experimental	a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.	Diagnostic Test: 3D printed model
Arm 2: No 3D printed model	No Intervention	Participants will have a standard-of-care surgical consultation using traditional breast imaging.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D printed model	Diagnostic Test	scan	Arm 1: 3D printed model

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lauren Chang Sen, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided