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

NCT03949491 | Terminated

• 1 other identifier: CASE6118
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Aesthetic outcomes as measured by the Harris scale

  Up to 1 year after reconstruction

• Donor site complications

  Up to 1 year after reconstruction

• Incidence of fat necrosis as measured by a grading system

  1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction.

• Patient satisfaction as measured by BREAST-Q scores

  Up to 1 year after reconstruction

Study Arms (1)

3-D virtual planning and medical modeling of breast

EXPERIMENTAL

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

Interventions

3D medical models 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

3-D virtual planning and medical modeling of breast

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Amir Ghaznavi

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 14, 2019
• Study Start: December 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: at the conclusion of study and for 5 years
• Access Criteria: data requestor will need to sign a data access agreement.

Locations

US (1)