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

摘要 乳腺癌是美国女性癌症死亡的第二大原因。乳房重建术 外科手术是乳腺癌治疗过程中的一个重要组成部分，用于重建乳房形态 由于癌症手术，已经被移除了。它是提高癌症患者健康相关质量不可或缺的一部分 生活的一部分。然而，手术的计划和评估是主观完成的，结果并不总是如此。 在审美上令人满意。 乳房重建的标准在过去20年里不断演变，患者和外科医生 同样期待自然的、看起来对称的手术结果。外科医生依靠他们的个人经验和 主观视觉评估技能才能达到这些效果。同样，审美结果评估 手术后的方法是相当主观的，并基于观察者对手术后生理变化的评估。 乳房形态和对称性。随着最近三维(3D)成像的发展，现在有了 开发允许使用乳房形态测量和计算机模拟的软件的机会 治疗计划、临床会诊和术后结果的客观评估。目前，有 外科医生没有独立的、独立于成像设备的软件来自动进行客观的测量 制定手术计划或生成逼真的乳房形状模拟。 为了应对这一挑战，我们建议开发用于乳房定量评估的软件 形状。3D成像已被证实可用于乳房美学的临床评估，但应用有限 用于模拟和手术计划，因为成像设备成本过高(约100-30万美元)，且缺乏 适当的图像分析工具。低成本(约8K)、便携式手持3D扫描仪现已上市，但 目前还缺乏用于外科手术计划的乳房形态测量分析软件。在这项第一阶段STTR研究中， 软成像有限责任公司正在与休斯顿大学(UH)和德克萨斯大学MD安德森大学合作 癌症中心将开发3D图像分析软件，该软件将利用创新和新颖的3D图像分析 实现(1)乳房形态测量和手术规划的自动化方法的算法和(2)使用 提出了一种基于三维球谐函数(SPHARM)的乳房形状参数化建模方法 临床会诊期间可视化的真实模拟。这将帮助乳腺癌患者 关于乳房重建治疗选择的明智决定，校准她的期望，并成为更多 对她的治疗选择感到满意。 在第一阶段可行性研究完成后，未来的第二阶段项目将开发一个原型，用于 在多个地点进行临床测试，然后是第三阶段商业化。美容产品将改善乳房 以几种方式进行癌症护理，例如：手术计划，实现手术结果的个性化模拟， 外科教育，以及手术康复期间使用的舒适的术后服装(胸罩)的规划。

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.