Patient-specific 3D-printed breast molds for shaping tissue during autologous reconstruction
Interactive Design of Patient-Specific Molds for Tissue Shaping
This project will test whether 3D-printed, patient-specific breast molds help surgeons shape tissue faster and more consistently during autologous breast reconstruction for adults after mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06711965 on ClinicalTrials.gov |
What this trial studies
Surgeons will use clinical decision-support algorithms to design patient-specific breast molds that are produced with 3D printing and used intraoperatively during autologous free-flap reconstruction (DIEP or TRAM). Participants will be enrolled into intervention and control groups to compare outcomes with and without the custom mold. The primary outcome focuses on operative efficiency for tissue shaping, while secondary outcomes include number of mold uses, intraoperative shaping time, aesthetic revision rates, and postoperative complications. Results will inform the practical utility of the algorithms and molds for routine reconstructive practice.
Who should consider this trial
Good fit: Adults (18+) who can provide informed consent and are scheduled for autologous breast reconstruction using DIEP or TRAM free flaps are ideal candidates.
Not a fit: Patients planned for stacked flaps, DIEP with vascularized lymph node transfer, those receiving neoadjuvant radiation, or patients undergoing implant-based reconstruction are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, patient-specific molds could shorten operative time and improve cosmetic results after autologous breast reconstruction.
How similar studies have performed: Prior case series and small studies using 3D-printed templates or surgical guides in breast and reconstructive surgery have shown promising feasibility and aesthetic improvements, but randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ashleigh M Francis, MD — M.D. Anderson Cancer Center
- Study coordinator: Ashleigh M Francis, MD
- Email: amfrancis@mdanderson.org
- Phone: 713-563-4598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.