A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction

Mayo Clinic

Status: Enrolling

Conditions: Breast Carcinoma

Treatments: Procedure: Computer-Aided Diagnosis; Other: Questionnaire Administration; Procedure: Prosthetics Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07047872

NCI-2024-10468 (Registry Identifier)

24-004692 (Other Identifier)

Details and patient eligibility

About

This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is customized to the patient using 3D imaging along with computer-aided design (CAD) to interpret the 3D imaging to develop and print a patient-specific external breast prosthesis. This may create a better fitting prosthesis which may improve PRO.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult individuals aged 18 years or older
• Have undergone mastectomy for breast cancer treatment without subsequent breast reconstruction
• Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
• Ability to provide informed consent

Exclusion criteria

• Individuals with contraindications for participation, such as severe medical conditions that may interfere with study procedures
• Lack of willingness or capacity to provide informed consent for study participation
• Inability to communicate effectively in the study language (e.g., English)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Supportive care (3D-printed external breast prosthesis)

Experimental group

Description:

Patients undergo CT, development of a patient-specific external breast prosthesis model using CAD, and measurements for 3D-printed external breast prosthesis during screening. Patients then undergo fitting for and receive the 3D-printed external breast prosthesis on study.

Treatment:

Procedure: Prosthetics Intervention

Other: Questionnaire Administration

Procedure: Computer-Aided Diagnosis

Procedure: Prosthetics Intervention

Procedure: Prosthetics Intervention