Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Breast Reconstruction

Treatments: Procedure: 3D medical models

Study type: Interventional

Funder types: Other

Identifiers

NCT03949491

CASE6118

Details and patient eligibility

About

The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.

Full description

Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.

Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.

This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction

Enrollment: 38 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction.
• Performance statusECOG Performance status ≤ 2
• Subjects must have normal organ and marrow function as defined below:
• Hemoglobin ≥ 10.0 g/dl
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Total bilirubin within normal institutional limits
• AST (SGOT) ≤ 2.5 X institutional upper limit of normal
• ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
• Serum Creatinine within normal institutional limits
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast.
• Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued.
• Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

3-D virtual planning and medical modeling of breast

Experimental group

Description:

3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction. * Preoperative CT-Angiogram of the abdominal wall * Volumetric analysis preformed * 3D printed models made * Pre operative BREAST-Questionnaires given * Free tissue transfer performed: Operative/Dissection Time Recorded * Flap/Abdominal donor site complications recorded * Standard Digital Photography and Harris Scoring * BREAST-Questionnaires given at 3, 6 months

Treatment:

Procedure: 3D medical models