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

March 1, 2024 updated by: M.D. Anderson Cancer Center
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Lauren Chang Sen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: 3D printed model
a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.
Diagnostic test: 3D printed model
scan
No Intervention: Arm 2: No 3D printed model
Participants will have a standard-of-care surgical consultation using traditional breast imaging.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

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

Investigators

  • Principal Investigator: Lauren Chang Sen, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1201
  • NCI-2023-01852 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on 3D printed model

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe