Staging of upper tract urothelial cancer with optical coherence tomography

光学相干断层扫描对上尿路尿路上皮癌的分期

• 批准号: 8256928
• 负责人: ANDREW Martin ROLLINS
• 金额: $ 30.4万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-17 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8256928
• 关键词: Biological Preservation; Biopsy; Bladder; Carcinoma in Situ; Clinical; Clinical Management; Comorbidity; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Early treatment; Esophageal; Excision; Family suidae; Fiber Optics; Future; Gold; Histologic; Histology; Image; In Situ; Left; Malignant Neoplasms; Malignant neoplasm of prostate; Malignant neoplasm of urinary bladder; Microscopic; Morbidity - disease rate; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Patient Schedules; Patients; Percutaneous Nephrostomy; Perforation; Performance; Pilot Projects; Recovery; Recruitment Activity; Renal function; Renal pelvis; Risk; Safety; Scanning; Sensitivity and Specificity; Shapes; Side; Specimen; Speed; Staging; Staging System; Structure; System; Technology; Testing; Time; Tissues; Training; Transitional Cell Carcinoma; Tubular formation; Tumor stage; Ureter; Ureteroscopy; Urinary tract; Urologist; Ursidae Family; Validation; base; bladder transitional cell carcinoma; cohort; cost; design; follow-up; imaging probe; improved; instrumentation; new technology; prototype; safety testing; standard care; success; treatment planning; tumor; urologic

DESCRIPTION (provided by applicant): Diagnosis and treatment of upper-tract urothelial carcinomas (UTUC) remain very challenging for urologists. Standard management for many years has been radical nephroureterectomy (RNU). However, RNU is a significant over-treatment for low-risk tumors, which have low rate of progression. Endoscopic management of these low-risk cases bears obvious advantages over RNU, including lower co-morbidity and lower cost, and would be highly feasible if accurate diagnosis can be made. The success of endoscopic management relies on accurate identification of low-grade and low-stage tumors, but staging of UTUC is very difficult even through biopsy. Usually, adequate tissue specimens for pathohistological staging cannot be acquired because of the limited manipulation space in the ureter and renal pelvis and the potential risk of perforating thin ureteral wall if deep biopsyis attempted. Therefore, urologists typically make a diagnosis only based on the tumor grade, which is also inefficient because of the limitations of biopsy, and which, alone, is not sufficientto make certain treatment decisions. Therefore, if the stage of UTUC could be safely and reliably identified, urologists would have complete information for diagnosis, which could significantly improve endoscopic management of UTUC. We propose to stage UTUC through endoscopic optical coherence tomography (OCT). The feasibility of this in situ imaging approach is supported by the fact that OCT has already been shown to be able to stage bladder urothelial cancer, which is histologically similar to UTUC and uses the same staging system as UTUC. We have demonstrated that OCT can acquire high-quality images of the ureter through a probe ex vivo. In this project, we will implement OCT probes specifically for imaging of UTUC and test the safety and preliminary efficacy of staging of UTUC in a two-stage pilot study, including a training stage and a testing stage. Success of this project will result in: (a) an endoscopic OCT system designed and proven safe for UTUC imaging, (b) tested OCT image-based diagnostic criteria, and (c) a preliminary estimate of the accuracy of OCT staging of UTUC. This will justify and set the stage for larger scale clinical validation. PUBLIC HEALTH RELEVANCE: Endoscopic treatment of early-stage upper-tract urothelial cancer (UTUC) could be cheaper and better for the patient than radical surgery, which is the standard care, but it can't currently be reliably used because no technology is available to accurately stage UTUC. This project will validate use of endoscopic OCT imaging to stage UTUC safely and quickly.

描述（由申请人提供）：上尿路尿路上皮癌（UTUC）的诊断和治疗对于泌尿科医生来说仍然非常具有挑战性。多年来的标准治疗一直是根治性肾输尿管切除术（RNU）。然而，RNU 对于进展率较低的低风险肿瘤来说是一种严重的过度治疗。内镜治疗这些低风险病例比RNU具有明显的优势，包括较低的合并症和较低的费用，如果能够做出准确的诊断，则具有很高的可行性。内镜治疗的成功依赖于对低级别和低分期肿瘤的准确识别，但即使通过活检对UTUC进行分期也非常困难。通常，由于输尿管和肾盂的操作空间有限，并且如果尝试进行深层活检，则可能存在穿孔薄输尿管壁的潜在风险，因此无法获得足够的组织标本用于病理组织学分期。因此，泌尿科医生通常仅根据肿瘤分级进行诊断，由于活检的局限性，这也是低效的，并且仅凭肿瘤分级不足以做出某些治疗决策。因此，如果能够安全可靠地识别 UTUC 的分期，泌尿科医生将拥有完整的诊断信息，这可以显着改善 UTUC 的内镜治疗。我们建议通过内窥镜光学相干断层扫描（OCT）对 UTUC 进行分期。这种原位成像方法的可行性得到了以下事实的支持：OCT 已被证明能够对膀胱尿路上皮癌进行分期，膀胱尿路上皮癌在组织学上与 UTUC 相似，并使用与 UTUC 相同的分期系统。我们已经证明 OCT 可以通过离体探针获取输尿管的高质量图像。在这个项目中，我们将实施专门用于 UTUC 成像的 OCT 探头，并在两阶段试点研究中测试 UTUC 分期的安全性和初步有效性，包括培训 阶段和测试阶段。该项目的成功将导致：(a) 设计并证明对 UTUC 成像安全的内窥镜 OCT 系统，(b) 测试基于 OCT 图像的诊断标准，以及 (c) 对 UTUC OCT 分期准确性的初步估计。这将为更大规模的临床验证提供合理性并奠定基础。 公共健康相关性：早期上尿路尿路上皮癌 (UTUC) 的内窥镜治疗可能比根治性手术更便宜、效果更好，但根治性手术是标准护理，但目前无法可靠使用，因为没有可用的技术准确分期 UTUC。该项目将验证使用内窥镜 OCT 成像安全、快速地对 UTUC 进行分期。