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

NCT07047872 | Recruiting

• 2 other identifiers: 24-004692NCI-2024-10468
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Patient-reported satisfaction with appearance

  Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.

  At baseline, 1 month, 3 months, 6 months, and 1 year

• Patient-reported emotional well-being

  Will be assessed by a an Emotional Response survey, which consists of 12 questions answered on a five-point Likert scale ranging from strongly disagree to strongly agree.

  At baseline, 1 month, 3 months, 6 months, and 1 year

Secondary Outcomes (3)

• Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis

  At baseline, 1 month, 3 months, 6 months, and 1 year

• Patient-reported fit of personalized 3D-printed breast prosthesis

  At baseline, 1 month, 3 months, 6 months, and 1 year

• Patient-reported satisfaction with personalized 3D-printed breast prosthesis

  At baseline, 1 month, 3 months, 6 months, and 1 year

Study Arms (1)

Supportive care (3D-printed external breast prosthesis)

EXPERIMENTAL

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.

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

Interventions

Computer-Aided Diagnosis PROCEDURE

Undergo CAD development for patient-specific external breast prosthesis model

Also known as: CAD

Supportive care (3D-printed external breast prosthesis)

Prosthetics Intervention PROCEDURE

Undergo measurements for external breast prosthesis

Supportive care (3D-printed external breast prosthesis)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (3D-printed external breast prosthesis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult individuals aged 18 years or older
• History of unilateral or bilateral mastectomy for any indication
• No implant or autologous reconstruction
• Allowed: Goldilocks closure, flat closure, simple skin closure
• Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
• Ability to provide informed consent
• Ability to complete study procedures, including surface scanning (with temporary fiducial skin markers), standardized photography, and surveys at 1, 3, 6, and 12 months

You may not qualify if:

• 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)
• Patients with open wounds, active infection, or dermatologic conditions at the chest/breast site that would interfere with scanning, fiducial marker placement, or prosthesis use
• Patients unwilling or unable to undergo surface scanning, standardized photography, or complete survey follow-up

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

• Aparna Vijayasekaran, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Sandhya Pruthi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aparna Vijayasekaran

CONTACT

507-538-1701; vijayasekaran.aparna@mayo.edu

Nicole G. Sanchez Figueroa, MD, MS

CONTACT

507-538-6419; sanchezfigueroa.nicole@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 2, 2025
• Study Start: November 5, 2024
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 5, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)