Interactive Design of Patient-Specific Molds for Tissue Shaping
2 other identifiers
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedStudy Start
First participant enrolled
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
April 16, 2026
April 1, 2026
3 years
November 18, 2024
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse eEents (AEs)
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.
Study Arms (2)
Intraoperative Use of 3D Printed Breast Mold
EXPERIMENTALParticipants will be randomized using a 1:1 ration to 1 of 2 conditions
Standard of Care Reconstruction
EXPERIMENTALParticipants will be randomized using a 1:1 ration to 1 of 2 conditions
Interventions
Participants will receive standard of care reconstruction
Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Ashleigh M Francis, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
December 2, 2024
Study Start
July 17, 2025
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04