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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Procedure: 3D medical models


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-D virtual planning and medical modeling of breast<br>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 | Procedure: 3D medical models<br>* 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 both operative time and dissection time. This will also allow for the proposal of 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, decrease donor site complications and improve patient satisfaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean operative time | Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. | Up to 6 months after reconstruction | 
| Mean dissection time | Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. | Up to 6 months after reconstruction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic outcomes as measured by the Harris scale | Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes. | Up to 1 year after reconstruction | 
| Donor site complications | Number of donor site complications will be reported | Up to 1 year after reconstruction | 
| Incidence of fat necrosis as measured by a grading system | Incidence of fat necrosis will be measured in the postoperative period using a classification system. Grade I necrosis will be defined as minimal requiring no surgical intervention; Grade II necrosis will be minor with some aesthetic defect requiring primary excision and closure; Grade III necrosis will be defined as requiring secondary procedures after excision to achieve satisfactory cosmesis; Grade IV necrosis will involve a necrosectomy requiring a either a completely new flap or at least a second flap to address such problems; Grade V necrosis will be defined as complete flap failure 5. Higher grade of fat necrosis is worse. | 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction. | 
| Patient satisfaction as measured by BREAST-Q scores | Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts. | Up to 1 year after reconstruction |