Breast CarcinomaNCT07047872
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
A study testing Computer-Aided Diagnosis, Prosthetics Intervention and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Computer-Aided Diagnosis, Prosthetics Intervention and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 5 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Nicole G. Sanchez Figueroa, 507-538-6419, sanchezfigueroa.nicole@mayo.edu
Clinical Trials G. Referral Office, MD, MS, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses
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
- Being tested
- Computer-Aided Diagnosis, Prosthetics Intervention, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Aided DiagnosisProcedure or surgery
Also called CAD
Undergo CAD development for patient-specific external breast prosthesis model
Prosthetics InterventionProcedure or surgery
Undergo measurements for external breast prosthesis
Prosthetics InterventionProcedure or surgery
Undergo fitting for 3D-printed external breast prosthesis
Prosthetics InterventionProcedure or surgery
Receive 3D-printed external breast prosthesis
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computer-Aided Diagnosis; Procedure: Prosthetics Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported satisfaction with appearance
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Measured: 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.
Measured: 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
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Measured: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported fit of personalized 3D-printed breast prosthesis
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Measured: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported satisfaction with personalized 3D-printed breast prosthesis
Will be assessed by a Prostheses Evaluation survey, which consists of 11 questions answered on a five-point Likert scale ranging from very dissatisfied to very satisfied.
Measured: At baseline, 1 month, 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start5 Nov 2024
- Primary completion5 Nov 2027 (estimated)
- Study completion5 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aparna Vijayasekaran, MBBS, Principal investigator, Mayo ClinicSandhya Pruthi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047872
- Sponsor's protocol ID
- 24-004692
- Other IDs
- NCI-2024-10468, 24-004692
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses
- ClinicalTrials.gov ID
- NCT07047872
- Acronym / sponsor ID
- 24-004692
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 5 Nov 2027 (estimated)
- Study completion
- 5 Nov 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (3D-printed external breast prosthesis) | Experimental | Procedure: Computer-Aided Diagnosis, Procedure: Prosthetics Intervention, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult individuals aged 18 years or older
- History of unilateral or bilateral mastectomy for any indication
- No implant or autologous reconstruction
- Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Aided DiagnosisAlso: CADUndergo CAD development for patient-specific external breast prosthesis model | Procedure or surgery | Supportive care (3D-printed external breast prosthesis) |
| Prosthetics InterventionUndergo measurements for external breast prosthesis | Procedure or surgery | Supportive care (3D-printed external breast prosthesis) |
| Prosthetics InterventionUndergo fitting for 3D-printed external breast prosthesis | Procedure or surgery | Supportive care (3D-printed external breast prosthesis) |
| Prosthetics InterventionReceive 3D-printed external breast prosthesis | Procedure or surgery | Supportive care (3D-printed external breast prosthesis) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (3D-printed external breast prosthesis) |
Primary outcome
Patient-reported satisfaction with appearance
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Patient-reported emotional well-being
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
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.
3 secondary outcomes
Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported fit of personalized 3D-printed breast prosthesis
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported satisfaction with personalized 3D-printed breast prosthesis
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aparna Vijayasekaran, MBBS principal investigator
Mayo Clinic
Sandhya Pruthi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Aided Diagnosis, Prosthetics Intervention and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aparna Vijayasekaran (507-538-1701, vijayasekaran.aparna@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported satisfaction with appearance (time frame: At baseline, 1 month, 3 months, 6 months, and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.