Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06711965

Conditions

Mastectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of care reconstruction

Surgery, Breast Mold

Study Details

Brief 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.

Conditions

Mastectomy

Study ID

NCT06711965

Start date

Mar 2, 2026

Status verified date

Aug, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intraoperative Use of 3D Printed Breast Mold

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

experimental: Standard of Care Reconstruction

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Interventions

Standard of care reconstruction

Participants will receive standard of care reconstruction

Surgery, Breast Mold

Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.

Primary outcome measure

  • Safety and Adverse eEents (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Ashleigh M Francis, MD

713-563-4598amfrancis@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ashleigh M Francis, MD

713-563-4598amfrancis@mdanderson.org

Principal Investigator:

Ashleigh M Francis, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-05.