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