RecruitingNot Applicable

Interactive Design of Patient-Specific Molds for Tissue Shaping

United States160 participantsStarted 2026-03-02

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and Adverse eEents (AEs)

Timeframe: Through study completion; an average of 1 year.

Trial details

NCT IDNCT06711965

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-01

Contact for this trial

Ashleigh M Francis, MD

713-563-4598 amfrancis@mdanderson.org

View on ClinicalTrials.gov More Mastectomy trials