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

M.D. Anderson Cancer Center

Status

Suspended

Conditions

Breast Cancer

Treatments

Diagnostic Test: 3D printed model

Study type

Interventional

Funder types

Other

Identifiers

NCT05755984

NCI-2023-01852 (Other Identifier)

2021-1201

Details and patient eligibility

About

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

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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