3D Image Analysis Software for Breast Reconstruction Surgical Planning, Outcome Assessment & Clinical Consultation

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Abstract Breast cancer is the second leading cause of cancer death in American women. Breast reconstruction surgery is an important component of the breast cancer treatment process, that is used to rebuild a breast form that has been removed due to cancer surgery. It is integral to improving the cancer patient's health-related quality of life. However, planning and evaluation of the surgery are done subjectively, and the result is not always aesthetically satisfactory. Standards for breast reconstruction have evolved over the past two decades, and patients and surgeons alike expect natural, symmetrical -looking surgical outcomes. Surgeons rely on their personal experience and on subjective visual assessment skills to achieve these results. Similarly, aesthetic outcome assessment methods, following surgery, are rather subjective, and are based on observer evaluation of physical changes in breast morphology and symmetry. With recent developments in three-dimensional (3D) imaging, there is now an opportunity to develop software that permit use of breast morphometry and computerized simulations for treatment planning, clinical consultation, and objective assessment of postoperative results. Currently, there is no stand-alone, imaging-device independent software for a surgeon to automate measurements for objectively formulating a surgical plan or generate realistic simulations of breast shape. To address this challenge, we propose the development of software for quantitative assessment of breast shape. 3D imaging has been validated for the clinical assessment of breast aesthetics but has seen limited use for simulation and surgical planning due to the exorbitant costs (~$100-300K) of imaging equipment and lack of appropriate image analysis tools. Low-cost (~8K), portable hand-held 3D scanners are now available, but software for enabling breast morphometric analysis for surgical planning is lacking. In this Phase I STTR study, Soft Imaging, LLC is collaborating with the University of Houston (UH) and The University of Texas MD Anderson Cancer Center to develop 3D image analysis software that will utilize innovative and novel 3D image analysis algorithms for enabling (1) automated approaches for breast morphometry and surgical planning and (2) employ a parametric modeling approach based on 3D spherical harmonics (SPHARM) to model breast shape, to provide realistic simulations for visualization during clinical consultations. This will help breast cancer patients make informed decisions about their breast reconstruction treatment choices, calibrate her expectations, and be more comfortable with her treatment choices. At the completion of this Phase I feasibility study, a future Phase II project, will develop a prototype for clinical testing at multiple sites, followed by Phase III commercialization. Applications would improve breast cancer care in several ways, such as; surgical planning, enabling personalized simulations of surgical outcomes, surgical education, and planning of comfortable postoperative garments (bras) for use during surgical recovery.