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）：对尿路上皮癌（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，标准管理一直是根治性的肾上部切除术（RNU）。然而，对于低风险肿瘤的RNU是一个显着的过度治疗，该肿瘤的进展速度较低。这些低风险病例的内窥镜治疗比RNU具有明显的优势，包括较低的合并症和较低的成本，如果可以进行准确的诊断，将是高度可行的。内窥镜管理的成功依赖于对低度和低阶段肿瘤的准确鉴定，但是即使通过活检，UTUC的分期也非常困难。通常，由于输尿管和肾脏骨盆中的操纵空间有限，并且如果尝试进行深度活检，则无法获得适当的病原体组织样品进行病理学分期分期。因此，泌尿科医生通常仅基于肿瘤等级进行诊断，由于活检的局限性，这也是效率低下的，并且仅仅是足够的来做出某些治疗决定。因此，如果可以安全可靠地确定UTUC的阶段，则泌尿科医生将拥有完整的诊断信息，这可以显着改善UTUC的内窥镜管理。我们建议通过内窥镜光学相干断层扫描（OCT）进行UTUC。这种原位成像方法的可行性得到了以下事实的支持：OCT已被证明能够进行膀胱尿路上皮癌，这在组织学上与UTUC相似，并且使用与UTUC相同的分期系统。我们已经证明，OCT可以通过探针离体获得输尿管的高质量图像。在该项目中，我们将专门实施OCT探针，用于对UTUC进行成像，并在两阶段的试点研究中测试UTUC分期的安全性和初步疗效，包括培训 舞台和测试阶段。该项目的成功将导致：（a）设计和证明可用于UTUC成像的内窥镜OCT系统，（b）经过测试的基于OCT图像的诊断标准，以及（c）对UTUC OCT阶段准确性的初步估计。这将证明并为大规模的临床验证奠定了基础。 公共卫生相关性：对早期尿中上皮癌（UTUC）的内窥镜治疗对患者的尿路癌（UTUC）可能比激进手术更便宜，更高，这是标准护理，但目前无法可靠地使用它，因为没有任何技术可以准确地进行UTUC。该项目将验证使用内窥镜OCT成像安全，迅速地上台。