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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decision Conflict Scale (DCS) score questionnaires

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
2,973 Previous Clinical Trials
1,789,146 Total Patients Enrolled
147 Trials studying Breast Cancer
63,086 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this experiment?

"According to clinicaltrials.gov, this medical trial which was initially posted on July 31st 2023 is no longer recruiting patients. The latest edits were made on February 23rd 2023 and, though it isn't actively looking for enrollees now, there are over 2 thousand other studies that currently need participants."

Answered by AI

Is the Arm 1: 3D printed model secure for utilization by patients?

"We have assigned a rating of 2 to Arm 1: 3D printed model due to the Phase 2 trial status, which suggests that there is some evidence indicating safety but none confirming efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
3D Printed Breast Models in the Surgical Management of Breast Cancer
2024. "3D Printed Breast Models in the Surgical Management of Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05755984.
~133 spots leftby Feb 2026
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