Optically-Guided Bladder Biopsy Using Polarized Elastic Scattering Spectroscopy

使用偏振弹性散射光谱进行光引导膀胱活检

• 批准号: 7480878
• 负责人: Frederick George Bargoot
• 金额: $ 14.97万
• 依托单位: OPTIMUM TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-14 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7480878
• 关键词: Abnormal Cell; Achievement; Address; Adjuvant Therapy; Adult; Algorithms; Architecture; Area; Atlas of Cancer Mortality in the United States; Benign; Biological Markers; Biopsy; Biopsy Specimen; Bladder; Bladder Tissue; Boston; Cancer Detection; Cancerous; Carcinoma; Catheters; Cessation of life; Class; Classification; Clinical; Clinical Research; Collaborations; Compatible; Computer software; Consent Forms; Core Biopsy; Cystoscopes; Cystoscopy; Data; Data Analyses; Data Set; Depth; Detection; Development; Devices; Diagnosis; Diagnostic; Discrimination; Distress; Doctor of Philosophy; Dyes; Early Diagnosis; Elastic scattering spectroscopy; Electrocoagulation; Electronics; Endoscopy; Ensure; Excision; Excision biopsy; Face; Feasibility Studies; Feedback; Fiber Optics; Forcep; Frequencies; Goals; Gold; Grant; Health Care Costs; Hematuria; Histology; Histopathology; Image; Institutes; Interstitial Cystitis; Intervention; Invasive; Jaw; Lead; Lesion; Light; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Maps; Measurement; Medical Surveillance; Methods; Modality; Monitor; Multi-Institutional Clinical Trial; Normal tissue morphology; Operative Surgical Procedures; Optical Biopsy; Optics; Outcome; Outcome Measure; Patients; Phase; Physicians' Offices; Population; Postoperative Period; Predictive Value; Procedures; Public Health; Quality of life; Range; Rate; Recurrence; Relative (related person); Research; Research Ethics Committees; Scanning; Schedule; Screening procedure; Sensitivity and Specificity; Site; Spectrum Analysis; Speed; Staging; Standards of Weights and Measures; Stress; Symptoms; System; Technology; Testing; TimeLine; Tissues; Training; Treatment Cost; Ultrasonography; United States; Universities; Urine; Urology; Urothelium; Visit; Visual; Work; abstracting; analytical tool; base; bladder Carcinoma; cancer diagnosis; cancer therapy; commercialization; cooking; cost; design; diagnosis standard; experience; follow-up; improved; in vivo; instrument; manufacturing process; millisecond; miniaturize; novel; outcome forecast; programs; prospective; prototype; research clinical testing; response; stem; technology development; tool; tumor; urologic

DESCRIPTION (provided by applicant): 6. Project Summary/Abstract This proposal is for the development of a fiber-optic based system for the detection and surveillance of early stage bladder cancer. The technology is based on Polarized Elastic Scattering Spectroscopy (PESS). Over 500,000 people in the US are afflicted with bladder cancer. Detection currently depends on visual examination by white light cystoscopy. This is generally performed when a patient presents with symptoms like hematuria or abnormal cells in the urine. This is followed by biopsy and surgical intervention. The recurrence rate for bladder cancer after surgery is an onerous 50-70%. This results in multiple repeat endoscopies and surgeries, with continued discomfort and stress to the patient. Bladder cancer is also the most expensive cancer, with an annual estimated cost in the US of $4B and a lifetime treatment cost for each surgical patient in the range of $100-200K. Early detection before the cancer reaches an invasive stage is often critical to long-term prognosis. The primary goals of this proposal are to determine the feasibility of using PESS for detecting early stage bladder cancer and developing PESS into a tool for optically guided interventions as well as a routine endoscopic screening tool for the doctor's office. Co-registration of a biopsy site with the site of spectroscopic measurement has been a consistent problem with optically and image-guided endoscopic and surgical interventions. To address this problem, a tool will be developed during this Phase 1 program that integrates a PESS fiber-optic probe with commercially-available biopsy forceps to ensure accurate correlation of histopathology with spectroscopic data. This optically-guided biopsy tool will be used in a 30-patient preliminary clinical study to acquire PESS spectra and histopathological assessments of samples biopsied from the same site. These data will be used to determine preliminary correlation between PESS spectral features and tissue histology for empirical classification of PESS spectra as indicative of normal urothelium, interstitial cystitis, low-grade bladder carcinoma, or high-grade bladder carcinoma. A successful Phase 1 outcome will lead to a broader multi-center Phase II clinical study, refined algorithms for tissue classification, and commercialization of the integrated optically-guided biopsy forceps. PESS has the potential to differentiate between normal and diseased tissues with sensitivity and specificity >90% using no indicator dyes, molecular markers, or other exogenous agents. Compared to imaging modalities such as NMR, CT and ultrasound, optically-guided PESS technology is simple, low cost, and easy to use with minimal training. PESS' ability to quickly detect lesions with high sensitivity and specificity can lead to fewer unnecessary tissue biopsies, earlier detection of recurrence, and reduced need for post-operative cystoscopic examinations, while reducing the cost of health care and improving patient outcomes and quality of life. OTI, with deep experience in optically- guided technology development, along with a world-class team of collaborators including Boston University, the Fraunhofer Institute, and Cook Urological, Inc. is uniquely equipped to successfully complete this program. 7. PUBLIC HEALTH RELEVANCE: Bladder cancer is the fifth most commonly diagnosed malignancy in the United States, and its high recurrence rate requires frequent post-operative visits for cystoscopic examination and surgery when new cancers are observed. Current clinical methods and practice are directed at surgically removing tumors identified visually or from biopsy of visually `suspicious' areas. If successful, the outcome of this grant will be a method of detecting bladder cancer before it is visible, allowing for earlier detection and treatment with fewer unnecessary tissue biopsies, a reduction in the need for post-operative follow-up and intervention, while reducing the cost of health care and improving patient outcomes and quality of life.

描述（由申请人提供）：6。项目摘要/摘要该建议是为了开发基于光纤的系统，用于检测和监视早期膀胱癌。该技术基于极化弹性散射光谱（PESS）。在美国，超过50万人患有膀胱癌。当前检测取决于白光膀胱镜检查的视觉检查。当患者表现出尿液中的血尿或异常细胞等症状时，通常会执行此操作。接下来是活检和手术干预。手术后膀胱癌的复发率为繁重的50-70％。这会导致多次重复内窥镜和手术，对患者持续不适和压力。膀胱癌也是最昂贵的癌症，在美国，估计为$ 4B，每位手术患者的终身治疗费用为100-2亿美元。在癌症达到侵入性阶段之前的早期发现对于长期预后通常至关重要。该提案的主要目标是确定使用PESS检测早期膀胱癌并将PESS开发成光学引导干预措施的工具以及医生办公室常规内窥镜筛查工具的可行性。与光谱测量部位共同注册活检部位是光学和图像引导的内窥镜和手术干预措施的一致问题。为了解决此问题，将在此阶段1程序中开发一种工具，该工具将pess光纤探针与商业上可用的活检镊子集成在一起，以确保组织病理学与光谱数据的准确相关性。这种光学引导的活检工具将用于30名专业初步临床研究中，以获取从同一站点活检的样品的PESS光谱和组织病理学评估。这些数据将用于确定PESS光谱特征与组织学之间的初步相关性，用于将PESS光谱的经验分类作为正常的尿路上皮，间质性膀胱炎，低度膀胱癌或高级膀胱癌的指示。成功的1阶段结果将导致更广泛的多中心II期临床研究，用于组织分类的精制算法以及综合光学引导的活检镊子的商业化。 PESS具有使用无指示剂染料，分子标记物或其他外源性剂的敏感性和特异性> 90％的正常组织和患病组织的潜力。与NMR，CT和Ultrasound等成像模式相比，光学引导的PESS技术是简单，低成本且易于使用的最小训练。 PESS快速检测具有高灵敏度和特异性病变的能力会导致不必要的组织活检，更早发现复发，并减少术后膀胱镜检查的需求，同时降低医疗保健的成本，并改善患者的成本和生活质量和生活质量。 OTI在光学指导技术开发方面具有丰富的经验，以及包括波士顿大学，弗劳恩霍夫研究所和库克乌拉术公司在内的世界一流合作者团队，具有独特的能力，可以成功完成该计划。 7。公共卫生相关性：膀胱癌是美国第五种最常见的恶性肿瘤，其高复发率需要经常进行术后就诊，以便在观察到新的癌症时进行膀胱镜检查和手术。当前的临床方法和实践是针对视觉上识别出的肿瘤或视觉上“可疑”区域的手术。如果成功的话，这笔赠款的结果将是一种在可见之前检测到膀胱癌的方法，允许使用不必要的组织活检进行早期检测和治疗，减少术后随访和干预的需求，同时减少医疗保健成本，并改善患者的兴趣和生活质量。