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

用于乳房重建手术规划、结果评估的 3D 图像分析软件

• 批准号: 10484568
• 负责人: Fatima Aziz Merchant
• 金额: $ 20.38万
• 依托单位: SOFT IMAGING, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484568
• 关键词: 3-Dimensional; Address; Algorithmic Analysis; American; Appearance; Autologous; Bilateral; Blinded; Body Image; Breast; Breast Cancer Patient; Breast Cancer Treatment; Breast Cancer survivor; Cancer Center; Cancer Etiology; Cancer Patient; Cancer Survivor; Caring; Cessation of life; Clinical; Clinical assessments; Communication; Computer Simulation; Computer software; Consultations; Data; Descriptor; Detection; Development; Equipment; Esthetics; Evaluation; Feasibility Studies; Future; Hand; Height; Image; Image Analysis; Imaging Device; Implant; Legal patent; Mammaplasty; Mastectomy; Measurement; Measures; Medical; Methods; Modeling; Morphology; Operative Surgical Procedures; Outcome; Outcome Assessment; Patient Preferences; Patient imaging; Patients; Performance; Personal Satisfaction; Phase; Postoperative Period; Procedures; Process; Ptosis; Quality of life; Reconstructive Surgical Procedures; Recovery; Research; Schedule; Shapes; Site; Small Business Technology Transfer Research; Somatotype; Surface; Surgeon; Surgical Oncology; Survivors; System; Three-Dimensional Image; Three-Dimensional Imaging; Time; Tissues; Universities; University of Texas M D Anderson Cancer Center; Visual; Visualization; Visualization software; Width; Woman; automated algorithm; automated analysis; base; cancer care; cancer surgery; clinical outcome assessment; clinically relevant; cohort; commercialization; cost; education planning; expectation; experience; health related quality of life; improved; innovation; malignant breast neoplasm; morphometry; multidisciplinary; novel; outcome prediction; patient expectation; phase 1 study; portability; preclinical evaluation; preference; prototype; quantitative imaging; reconstruction; research clinical testing; satisfaction; self esteem; side effect; simulation; skills; software development; success; surgery outcome; three-dimensional modeling; three-dimensional visualization; tool; treatment choice; treatment planning; usability; virtual surgery

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.

摘要 乳腺癌是美国女性癌症死亡的第二大原因。乳房再造 手术是乳腺癌治疗过程的重要组成部分，用于重建乳房形状 因为癌症手术而被切除了它是改善癌症患者健康相关质量的组成部分 生命然而，手术的计划和评估是主观完成的，结果并不总是 美学上令人满意。 乳房再造的标准在过去的二十年中不断发展，患者和外科医生 都希望手术效果自然对称。外科医生依靠他们的个人经验， 主观视觉评估技能来实现这些结果。同样，美学结果评估 方法，手术后，是相当主观的，是基于观察者的评价物理变化， 乳房形态和对称性。随着三维（3D）成像的最新发展，现在 有机会开发软件，允许使用乳房形态测量和计算机模拟， 治疗计划、临床咨询和术后结果的客观评估。目前还 没有独立的成像设备独立软件供外科医生自动测量， 制定手术计划或生成乳房形状的逼真模拟。 为了应对这一挑战，我们建议开发软件，用于定量评估乳腺癌 形状3D成像已被验证用于乳房美学的临床评估，但使用有限 由于成像设备成本过高（约10 - 30万美元）， 合适的图像分析工具。低成本（~ 8 K），便携式手持3D扫描仪现在可用，但 缺乏能够进行用于手术计划的乳房形态测量分析的软件。在这项I期STTR研究中， Soft Imaging，LLC与休斯顿大学（UH）和德克萨斯大学MD安德森大学合作 癌症中心开发3D图像分析软件，将利用创新和新颖的3D图像分析 用于实现（1）用于乳房形态测量和手术规划的自动化方法和（2）采用 一种基于3D球谐函数（SPHARM）的参数化建模方法来建模乳房形状， 在临床咨询期间进行逼真的模拟可视化。这将有助于乳腺癌患者 关于乳房重建治疗选择的知情决定，校准她的期望，并更多 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， 在多个地点进行临床试验，然后进行III期商业化。应用程序将改善乳房 癌症护理的几种方式，如：手术计划，使个性化的模拟手术结果， 手术教育和规划手术恢复期间使用的舒适术后服装（布拉斯）。