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Trial Title:
3D Printed Breast Models in the Surgical Management of Breast Cancer
NCT ID:
NCT05755984
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
3D printed model
Description:
scan
Arm group label:
Arm 1: 3D printed model
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Chang Sen, MD
Phone:
(713) 745-4555
Email:
lqchang@mdanderson.org
Contact backup:
Last name:
Lauren Chang Sen, MD
Start date:
February 29, 2024
Completion date:
February 28, 2028
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755984
http://www.mdanderson.org
