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 该提案旨在开发基于光纤的系统，用于检测和监测早期膀胱癌。该技术基于偏振弹性散射光谱（PESS）。美国有超过 500,000 人患有膀胱癌。目前的检测依赖于白光膀胱镜检查的目视检查。这通常在患者出现血尿或尿液中出现异常细胞等症状时进行。随后进行活检和手术干预。膀胱癌术后复发率高达50-70%。这导致多次重复内窥镜检查和手术，给患者带来持续的不适和压力。膀胱癌也是最昂贵的癌症，在美国每年的估计费用为 4B 美元，每位手术患者的终生治疗费用在 100-20 万美元之间。在癌症达到侵袭阶段之前的早期检测通常对于长期预后至关重要。该提案的主要目标是确定使用 PESS 检测早期膀胱癌的可行性，并将 PESS 开发为光学引导干预工具以及医生办公室的常规内窥镜筛查工具。活检部位与光谱测量部位的共同配准一直是光学和图像引导内窥镜和手术干预的一个一致问题。为了解决这个问题，第一阶段计划将开发一种工具，将 PESS 光纤探头与市售活检钳集成在一起，以确保组织病理学与光谱数据的准确关联。这种光学引导活检工具将用于一项 30 名患者的初步临床研究，以获取同一部位活检样本的 PESS 光谱和组织病理学评估。这些数据将用于确定 PESS 光谱特征和组织组织学之间的初步相关性，以对 PESS 光谱进行经验分类，以指示正常尿路上皮、间质性膀胱炎、低级别膀胱癌或高级别膀胱癌。第一阶段的成功结果将导致更广泛的多中心第二阶段临床研究、组织分类的改进算法以及集成光学引导活检钳的商业化。 PESS 具有区分正常组织和患病组织的潜力，无需使用指示剂染料、分子标记或其他外源试剂，其敏感性和特异性 >90%。与 NMR、CT 和超声等成像方式相比，光导 PESS 技术简单、成本低且易于使用，只需最少的培训。 PESS 能够以高灵敏度和特异性快速检测病变，从而减少不必要的组织活检、更早检测复发并减少术后膀胱镜检查的需要，同时降低医疗保健成本并改善患者的治疗结果和生活质量。 OTI 在光学引导技术开发方面拥有丰富的经验，并与包括波士顿大学、弗劳恩霍夫研究所和库克泌尿科公司在内的世界一流合作者团队一起，拥有独特的能力来成功完成该项目。 7. 公共健康相关性：膀胱癌是美国第五大最常诊断的恶性肿瘤，其高复发率需要频繁术后就诊进行膀胱镜检查，并在发现新癌症时进行手术。目前的临床方法和实践旨在通过手术切除肉眼识别的肿瘤或从肉眼“可疑”区域的活检中切除肿瘤。如果成功，这笔拨款的结果将是一种在膀胱癌可见之前进行检测的方法，从而可以通过减少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要，同时减少医疗保健成本以及改善患者的治疗结果和生活质量。