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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755984
• Other study ID #: 2021-1201
• Secondary ID: NCI-2023-01852
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: February 28, 2028

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Lauren Chang Sen, MD
• Phone: (713) 745-4555
• Email: lqchang[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• 3D printed model
scan

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   M D Anderson Cancer Center