Interactive Design of Patient-Specific Molds for Tissue Shaping

August 3, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M. D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Ashleigh M Francis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative Use of 3D Printed Breast Mold
Participants will be randomized using a 1:1 ration to 1 of 2 conditions
Procedure: Standard of care reconstruction
Participants will receive standard of care reconstruction
Experimental: Standard of Care Reconstruction
Participants will be randomized using a 1:1 ration to 1 of 2 conditions
Procedure: Surgery, Breast Mold
Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Ashleigh M Francis, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0265
  • NCI-2024-09605 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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