NCT06711965 Interactive Design of Patient-Specific Molds for Tissue Shaping
| NCT ID | NCT06711965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Mastectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2026-03-02 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ashleigh M Francis, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06711965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mastectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06711965 currently recruiting?
Yes, NCT06711965 is actively recruiting participants. Contact the research team at amfrancis@mdanderson.org for enrollment information.
Where is the NCT06711965 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06711965 clinical trial?
NCT06711965 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ashleigh M Francis, MD at M.D. Anderson Cancer Center. The trial plans to enroll 160 participants.