Staging of upper tract urothelial cancer with optical coherence tomography

描述（申请人提供）：上尿路上皮癌（UTUC）的诊断和治疗对于泌尿科医生来说仍然是非常具有挑战性的。多年来的标准治疗是根治性肾输尿管切除术（RNU）。然而，对于进展率低的低危肿瘤，RNU是一种明显的过度治疗。与RNU相比，内镜下治疗这些低危病例具有明显的优势，合并症少，费用低，如果能准确诊断，是非常可行的。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UTUC的分期即使通过活检也是非常困难的。通常，由于输尿管和肾盂的操作空间有限，并且如果进行深部活检，可能会穿孔薄输尿管壁，因此无法获得足够的组织标本进行病理组织学分期。因此，泌尿科医生通常仅根据肿瘤分级进行诊断，这也是低效的，因为活检的局限性，而且仅凭活检不足以做出某些治疗决定。因此，如果能够安全可靠地确定UTUC的分期，泌尿科医生将有完整的诊断信息，这将显著提高UTUC的内镜管理。我们建议通过内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OCT已经被证明能够分期膀胱尿路上皮癌的事实的支持，膀胱尿路上皮癌在组织学上与UTUC相似，并且使用与UTUC相同的分期系统。我们已经证明OCT可以通过离体探针获得输尿管的高质量图像。在这个项目中，我们将实施OCT探针专门用于UTUC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有效性，包括培训

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.