Interactive Design of Patient-Specific Molds for Tissue Shaping

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06711965
Status
Recruiting
Apply to this trial

Conditions

  • Mastectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 17, 2025
Status verified
Apr 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2030

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Ashleigh M Francis, MD
[email protected]
713-563-4598
Ashleigh M Francis, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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