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Interactive Design of Patient-Specific Molds for Tissue Shaping

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients who are willing and able to provide informed consent
3. 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:

1. Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
2. Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
3. Patients undergoing neoadjuvant radiation

About the 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.

What is being tested

• Standard of care reconstruction (procedure)
• Surgery, Breast Mold (procedure)

Sponsor: M.D. Anderson Cancer Center · Participants: 160 · Started: Mar 2, 2026

Contact the study team

• Ashleigh M Francis, MD · Phone: 713-563-4598

Official record on ClinicalTrials.gov — NCT06711965

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.