MastectomyNCT06711965
Interactive Design of Patient-Specific Molds for Tissue Shaping
A study testing Surgery, Breast Mold in people with Mastectomy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastectomy
- What is being tested?
- Surgery, Breast Mold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 1 Aug 2030
- 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
- Patients 18 years of age or older
- Patients who are willing and able to provide informed consent
- Patients who are scheduled to undergo breast reconstruction with free flap (Deep Interior Epigastric Artery Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap)
Who cannot join
- Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
- Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
- Patients undergoing neoadjuvant radiation
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
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Ashleigh M Francis, MD, 713-563-4598, amfrancis@mdanderson.org
Ashleigh M Francis, MD
About this study
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.
Read the detailed description
Primary Objective:
To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms.
Secondary Objectives:
To assess the total number of times the mold was used by the surgeons in the intervention group.
To compare the intraoperative time for shaping tissue in control versus intervention group.
To collect information on the type of revisions for aesthetic purposes required in control versus intervention group.
To assess the number and type of complications experienced in control versus intervention group.
- Conditions
- Mastectomy
- Being tested
- Standard of care reconstruction, Surgery, Breast Mold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care reconstructionProcedure or surgery
Participants will receive standard of care reconstruction
Surgery, Breast MoldProcedure or surgery
Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Use of 3D Printed Breast Mold | Experimental | Participants will be randomized using a 1:1 ration to 1 of 2 conditions Receives: Procedure: Standard of care reconstruction |
| Standard of Care Reconstruction | Experimental | Participants will be randomized using a 1:1 ration to 1 of 2 conditions Receives: Procedure: Surgery, Breast Mold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse eEents (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 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 Dec 2024
- Study start2 Mar 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashleigh M Francis, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711965
- Sponsor's protocol ID
- 2024-0265
- Other IDs
- NCI-2024-09605
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Design of Patient-Specific Molds for Tissue Shaping
- ClinicalTrials.gov ID
- NCT06711965
- Acronym / sponsor ID
- 2024-0265
- Conditions
- Mastectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 2 Dec 2024 (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.
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.
Detailed description
Primary Objective:
To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms.
Secondary Objectives:
To assess the total number of times the mold was used by the surgeons in the intervention group.
To compare the intraoperative time for shaping tissue in control versus intervention group.
To collect information on the type of revisions for aesthetic purposes required in control versus intervention group.
To assess the number and type of complications experienced in control versus intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Use of 3D Printed Breast Mold | Experimental | Procedure: Standard of care reconstructionParticipants will be randomized using a 1:1 ration to 1 of 2 conditions |
| Standard of Care Reconstruction | Experimental | Procedure: Surgery, Breast MoldParticipants will be randomized using a 1:1 ration to 1 of 2 conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Patients who are willing and able to provide informed consent
- Patients who are scheduled to undergo breast reconstruction with free flap (Deep Interior Epigastric Artery Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap)
Key exclusion criteria (3 listed)
- Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
- Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
- Patients undergoing neoadjuvant radiation
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 |
|---|---|---|
| Standard of care reconstructionParticipants will receive standard of care reconstruction | Procedure or surgery | Intraoperative Use of 3D Printed Breast Mold |
| Surgery, Breast MoldParticipants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts. | Procedure or surgery | Standard of Care Reconstruction |
Primary outcome
Safety and Adverse eEents (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ashleigh M Francis, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery, Breast Mold in people with Mastectomy, run by M.D. Anderson Cancer Center 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 3 inclusion and 3 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 6 Oct 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 Ashleigh M Francis, MD (713-563-4598, amfrancis@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse eEents (AEs) (time frame: Through study completion; an average of 1 year.). 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 6 Oct 2026.