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

Stopped early · Not applicable

Conditions studied: Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT03949491

Run by

Case Comprehensive Cancer Center

People needed

38

Starts

2020-12-01

Expected to finish

2022-08-01

Last updated by the study team

2024-02-07

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.