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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03949491
• Other study ID #: CASE6118
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Donor site complications	Number of donor site complications will be reported	Up to 1 year after reconstruction
Secondary	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.
Secondary	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