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NCT Number: NCT06711965

Interactive Design of Patient-Specific Molds for Tissue Shaping

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.

Recruiting

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Key information

Conditions

Mastectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Ashleigh M Francis, MD

CONTACT

[email protected]

713-563-4598

Ashleigh M Francis, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care reconstruction

Procedure

Participants will receive standard of care reconstruction

Surgery, Breast Mold

Procedure

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ashleigh M Francis, MD

CONTACT

[email protected]

713-563-4598

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Dec 2, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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