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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2028-02-28

Brief Summary

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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

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Detailed Description

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1: 3D printed model

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

Group Type EXPERIMENTAL

3D printed model

Intervention Type DIAGNOSTIC_TEST

scan

Arm 2: No 3D printed model

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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3D printed model

scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No