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3D Printed Models for Breast Cancer Surgery Planning

N/A
Recruiting
Led By Lauren Chang Sen, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older female
Patient is a candidate for surgical management
Must not have
Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare if 3-D printing can help breast cancer patients make decisions about their care. Some get 3-D models, some get traditional scans.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-invasive procedures, there are no direct side effects from the intervention itself. However, participants may experience different emotional or psychological responses based on the type of information they receive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.
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I am eligible for surgery.
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My breast cancer diagnosis was confirmed through a tissue sample.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had a mastectomy and my cancer has come back on the same side.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decision Conflict Scale (DCS) score questionnaires

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: 3D printed modelExperimental Treatment1 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 modelActive Control1 Intervention
Participants will have a standard-of-care surgical consultation using traditional breast imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3D printed model
2018
N/A
~470

Find a Location

Who is running the clinical trial?

University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer CenterUNKNOWN
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,345 Total Patients Enrolled
146 Trials studying Breast Cancer
63,002 Patients Enrolled for Breast Cancer
Lauren Chang Sen, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Arm 1: 3D printed model Clinical Trial Eligibility Overview. Trial Name: NCT05755984 — N/A
Breast Cancer Research Study Groups: Arm 2: No 3D printed model, Arm 1: 3D printed model
Breast Cancer Clinical Trial 2023: Arm 1: 3D printed model Highlights & Side Effects. Trial Name: NCT05755984 — N/A
Arm 1: 3D printed model 2023 Treatment Timeline for Medical Study. Trial Name: NCT05755984 — N/A
~117 spots leftby Feb 2026
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