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

NCT ID: NCT03949491

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-08-01

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

Conditions

Breast Reconstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

3-D virtual planning and medical modeling of breast

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

Group Type: EXPERIMENTAL

3D medical models

Intervention Type: PROCEDURE

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

Interventions

3D medical models

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amir Ghaznavi

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE6118

Identifier Type: -

Identifier Source: org_study_id