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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D printed model
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1: 3D printed model

Arm 2: No 3D printed model

Arm Description

a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.

Participants will have a standard-of-care surgical consultation using traditional breast imaging.

Outcomes

Primary Outcome Measures

Decision Conflict Scale (DCS) score questionnaires
Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
August 24, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05755984
Brief Title
3D Printed Breast Models in the Surgical Management of Breast Cancer
Official Title
3D Printed Breast Models in the Surgical Management of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: 3D printed model
Arm Type
Experimental
Arm Description
a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.
Arm Title
Arm 2: No 3D printed model
Arm Type
No Intervention
Arm Description
Participants will have a standard-of-care surgical consultation using traditional breast imaging.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D printed model
Intervention Description
scan
Primary Outcome Measure Information:
Title
Decision Conflict Scale (DCS) score questionnaires
Description
Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4
Time Frame
through study completion; an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Chang Sen, MD
Phone
(713) 745-4555
Email
lqchang@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Chang Sen, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Chang Sen, MD
Phone
713-745-4555
Email
lqchang@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lauren Chang Sen, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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