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）： 该提案的中心目标是证明与当前标准实践相比，光谱学在结直肠癌 (CRC) 筛查、管理和预防方面的优势。将使用同一平台测试两个互补的应用：使用弹性散射光谱 (ESS) 可靠地区分肿瘤性和非肿瘤性息肉，并使用 ESS、低相干增强背向散射光谱 (LEBS) 和部分波光​​谱 (PWS) 感测癌变场效应 (FEC)。具体目标是： 1. 利用 ESS 进行息肉实时组织学评估的前瞻性临床研究。我们将使用 ASGE-PIVI 指南作为性能基准，前瞻性地测试和验证我们为息肉 ESS 分类设计的算法。 2.场效应临床研究及组合应用研究。我们将在常规结肠镜检查过程中同时收集用于使用 ESS 感知 FEC 的算法训练和验证数据。对于相同的患者和相同的手术，我们将研究 ESS 作为 CRC 风险评估工具及其与提高发现肿瘤性息肉以进行息肉切除术的效率和成功率的关系（如果有的话）。此外，我们将使用 LEBS 获得的光学测量值和 PWS 分析的直肠刷牙来交叉验证 ESS 获得的 FEC 传感结果。 3. 仪器：实施系统增强和工具设计以提高临床友好性。我们将建立标准化和校准程序，使仪器能够适应临床环境的变化，并开发下一代临床硬件和软件接口。这将确保在不同的运营商和站点之间获得可比较的结果。将根据需要将 ESS 和 LEBS 集成到单个混合系统盒中。用于指导息肉切除术和 FEC 传感的内窥镜介导工具将被设计成低成本和一次性的。方法：本研究的候选受试者将从现有的患者库中抽取，这些患者由医生安排进行常规或监测结肠镜检查，或者作为先前临床评估或预先存在的病症的结果。在获得签署的知情同意书后，所有患者都将接受标准治疗。与正常检查和活检程序的主要偏差是在每次活检之前对周围结肠粘膜进行光学测量，并在结肠镜检查期间采集直肠样本进行刷细胞学检查。当需要活检时，在标准物理活检之前，将使用 ESS 光学钳对完全相同的组织进行光学活检。根据护理标准，活检将被送往组织病理学，并由三名对光谱结果不知情的独立病理学家进行审查。还将使用 ESS 对结肠的几个部分进行正常结肠粘膜的测量。此外，还将通过 LEBS 获得直肠粘膜的光学测量结果，并通过 PWS 分析直肠刷牙结果。息肉的 ESS 光谱将与病理学家的大多数诊断相关。根据手术过程中的发现，正常结肠组织的 ESS、LEBS 和 PWS 测量值将被分配为属于肿瘤或非肿瘤领域。将使用这些相关的光学数据来训练和测试诊断算法。用于识别 FEC 生物标志物的数据将从多个来源收集，以排除可能的混杂因素。