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

Not Applicable

Terminated

• Conditions: Breast Reconstruction
• Interventions: Procedure: 3D medical models

• Registration Number: NCT03949491
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2020-12-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3-D virtual planning and medical modeling of breast	3D medical models	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

Primary Outcome Measures

Name	Time	Method
Mean operative time	Up to 6 months after reconstruction	Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
Mean dissection time	Up to 6 months after reconstruction	Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.

Secondary Outcome Measures

Name	Time	Method
Aesthetic outcomes as measured by the Harris scale	Up to 1 year after reconstruction	Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes.
Donor site complications	Up to 1 year after reconstruction	Number of donor site complications will be reported
Incidence of fat necrosis as measured by a grading system	1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction.	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.
Patient satisfaction as measured by BREAST-Q scores	Up to 1 year after reconstruction	Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts.

Trial Locations

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States