Optical Spectroscopy in the Management of Colorectal Neoplasia

光谱学在结直肠肿瘤治疗中的应用

• 批准号: 8922125
• 负责人: SATISH K SINGH
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8922125
• 关键词: Algorithms; Benchmarking; Benign; Biological Markers; Biological Preservation; Biopsy; Blinded; Boston; Boxing; Calibration; Classification; Clinical; Clinical Research; Cohort Studies; Colon; Colonoscopy; Colorectal; Colorectal Cancer; Colorectal Neoplasms; Computer software; Cytology; Data; Diagnosis; Diagnostic; Distal; Effectiveness; Elastic scattering spectroscopy; Endoscopes; Endoscopy; Ensure; Environment; Evaluation; Excision; Forcep; Goals; Guidelines; Health; Health Care Costs; Healthcare; Healthcare Systems; Histology; Histopathology; Hybrids; In Situ; Informed Consent; Jamaica; Malignant - descriptor; Measurement; Mediating; Methodology; Methods; Mucous Membrane; Neoplasms; Neoplastic Polyp; Optical Biopsy; Optical Methods; Optics; Pathologist; Patient risk; Patients; Performance; Physicians; Polypectomy; Polyps; Precancerous Polyp; Prevention; Preventive; Procedures; Prospective Studies; Rectum; Research; Risk; Risk Assessment; Sampling; Schedule; Site; Societies; Source; Spectrum Analysis; Standardization; Stratification; Study Subject; System; Technology; Testing; Time; Tissues; Training; Universities; Validation; Variant; Veterans; Work; base; cancer risk; carcinogenesis; colorectal cancer prevention; colorectal cancer screening; cost; design; gastrointestinal; improved; in vivo; innovation; instrument; instrumentation; minimally invasive; neoplastic; next generation; prospective; public health relevance; rectal; research clinical testing; screening; standard care; standard of care; success; tool

 DESCRIPTION (provided by applicant): The central objective of this proposal is to demonstrate the benefits of optical spectroscopy for the screening, management, and prevention of colorectal cancer (CRC) as compared to current standard practices. Two complementary applications will be tested using the same platform: Using elastic-scattering spectroscopy (ESS) to distinguish reliably between neoplastic and non-neoplastic polyps, and using ESS, low- coherence enhanced backscattering spectroscopy (LEBS), and partial wave spectroscopy (PWS) for sensing the field effect of carcinogenesis (FEC). The specific objectives are: 1. To conduct a prospective clinical study using ESS for real-time histological assessment of polyps. We will prospectively test and validate algorithms that we have designed for ESS classification of polyps, using the ASGE-PIVI guidelines as performance benchmarks. 2. Clinical studies of field effect, and combined applications study. We will concurrently collect algorithm-training and validation data for sensing of FEC with ESS, during routine colonoscopy procedures. With the same patients and at the same procedure, we will look at ESS as a CRC risk assessment tool and its relationship, if any, with improvements in efficiency and success rate of finding neoplastic polyps for polypectomy. In addition, we will use optical measurements obtained with LEBS and rectal brushings analyzed with PWS to cross-validate FEC sensing results obtained with ESS. 3. Instrumentation: Implement system enhancements and tool design for clinical friendliness. We will establish standardization and calibration procedures to make instruments robust to variations in clinical environment, and develop next-generation clinical hardware and software interfaces. This will ensure that comparable results are obtained among different operators and sites. Integration of ESS and LEBS into a single hybrid system box will be enabled as required. Endoscope-mediated tools for guiding polypectomy and FEC-sensing will be designed to be low-cost and disposable. Methodology: Candidate subjects for this study will be drawn from an extant pool of patients who are scheduled for routine or surveillance colonoscopy by their physician or as the result of a prior clinical evaluation or a pre-existing condition. Upon obtaining a signed Informed Consent, all patients will receive standard treatment. The main deviation from the normal examination and biopsy procedure will be to take an optical measurement prior to each biopsy and of surrounding colonic mucosa, and a rectal sample for brush cytology during the colonoscopy. When biopsy is required, prior to the standard physical biopsy, an optical biopsy will be taken of the exact same tissue with the ESS optical forceps. The biopsy will be sent for histopathology, as per standard of care, and reviewed by three independent pathologists blinded to the spectroscopic results. Measurements of normal colonic mucosa will also be taken along several segments of the colon with ESS. Additionally, optical measurements of rectal mucosa will be obtained with LEBS, as well as rectal brushings that will be analyzed with PWS. ESS spectra from polyps will be correlated to the majority diagnosis from the pathologists. ESS, LEBS, and PWS measurements from normal colonic tissue will be assigned as to belonging to a neoplastic or non-neoplastic field based on findings during the procedure. Diagnostic algorithms will be trained and tested using these correlated optical data. Data for identification of FEC biomarkers will be collected from several sources to rule out possible confounders.

 描述（由申请人提供）： 该提案的核心目的是证明光谱法对筛查，管理和预防结直肠癌（CRC）（CRC）的好处，与当前的标准实践相比。将使用相同的平台对两个完整的应用进行测试：使用弹性散射光谱（ESS）可靠地区分肿瘤和非塑性息肉之间，以及使用ESS，低稳态增强的反向散射光谱（LEB）（LEB），部分波光谱（PWS），以感知视野效应的视野效应（FEX）。具体目标是：1。使用ESS进行息肉的实时组织学评估进行前瞻性临床研究。我们可能会使用ASGE-PIVI指南作为性能基准测试和验证我们为息肉分类设计的算法。 2。现场效应和联合应用研究的临床研究。在常规结肠镜检查过程中，我们将同时收集通过ESS传感FEC的算法培训和验证数据。通过相同的患者和相同的程序，我们将ESS视为CRC风险评估工具及其关系（如果有的话），以提高效率和成功率，以寻找杂型切除术的肿瘤息肉。此外，我们还将使用用LEB和PWS分析的直肠刷子获得的光学测量值来跨质量验证的FEC感应结果。 3。仪器：实施系统增强功能和工具设计，以实现临床友好性。我们将建立标准化和校准程序，以使工具适合临床环境的变化，并开发下一代临床硬件和软件接口。这将确保在不同的操作员和站点之间获得可比的结果。将根据需要启用将ESS和LEB集成到单个混合系统框中。内窥镜介导的指导息肉切除术和FEC感应的工具将设计为低成本和一次性。方法论：这项研究的候选受试者将从额外的患者群中提取，这些患者因其身体或先前的临床评估或预先存在的疾病而定于常规或监视结肠镜检查。在获得签署的知情同意书后，所有患者将获得标准治疗。主要偏离正常检查和活检程序将是在每次活检和周围的结肠粘膜之前进行光学测量，以及在结肠镜检查过程中进行刷细胞学的直肠样品。当需要进行活检时，在标准的身体活检之前，将使用ESS光钳对完全相同的组织进行光学活检。根据护理标准，将进行活检以进行组织病理学，并由三名独立病理学家对光谱结果视而不见。正常结肠粘膜的测量也将在结肠的几个段中进行ESS进行。此外，将通过LEB以及将用PWS分析的直肠刷子获得直肠粘膜的光学测量。来自息肉的ESS光谱将与病理学家的多数诊断相关。基于手术过程中的发现，将对正常结肠组织的ESS，LEB和PWS测量分配给属于肿瘤或非塑性场。诊断算法将使用这些相关的光学数据训练和测试。用于识别FEC生物标志物的数据将从几个来源收集，以排除可能的混杂因素。