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OpenTrials
Active, Not Recruiting

NCT Number: NCT05755984

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D printed model

Diagnostic Test

scan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 6, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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