Interactive Design of Patient-Specific Molds for Tissue Shaping

M.D. Anderson Cancer Center

Status: Begins enrollment this month

Conditions: Mastectomy

Treatments: Procedure: Standard of care reconstruction; Procedure: Surgery, Breast Mold

Study type: Interventional

Funder types: Other

Identifiers

NCT06711965

NCI-2024-09605 (Other Identifier)

2024-0265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intraoperative Use of 3D Printed Breast Mold

Experimental group

Description:

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Treatment:

Procedure: Standard of care reconstruction

Standard of Care Reconstruction

Experimental group

Description:

Participants will be randomized using a 1:1 ration to 1 of 2 conditions

Treatment:

Procedure: Surgery, Breast Mold