Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Scott Department of Urology, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX.
Department of Urology, New York Presbyterian Hospital, Weill Cornell Medicine, New York, NY.
Urol Oncol. 2021 Jul;39(7):434.e23-434.e29. doi: 10.1016/j.urolonc.2021.03.026. Epub 2021 Apr 29.
Optical coherence tomography (OCT) is a novel imaging modality that provides microstructural information of different tissue layers using near-infrared light. This prospective, multicenter phase II trial aimed to assess the accuracy of OCT-assisted cystoscopy for bladder tumor staging.
Patients with primary or recurrent bladder tumors (Ta,T1) identified by outpatient cystoscopy were included. The primary objective was to assess the accuracy and positive predictive value of for determining tumor stage ≥T1 correlated by histopathology. 72 suspicious lesions from 63 patients were eligible to analyze in the study. All suspected lesions were evaluated with conventional cystoscopy, interpreted in real-time using OCT, and then resected. All results were compared to pathology. A total of 363 OCT images of tumor and normal mucosa in 25 patients were obtained to evaluate diagnostic efficacy of the computer-aided texture analysis algorithm.
Sensitivity and specificity for predicting invasive tumors (≥ T1, n = 17) were 58.8% and 92.7% for cystoscopy, 64.7% and 100% for OCT-assisted cystoscopy, respectively. Accuracy of cystoscopy and OCT-assisted cystoscopy for predicting invasive tumor was 84.7% and 91.7% (P = 0.063), respectively. Cystoscopy and OCT-assisted cystoscopy correctly predicted T stage in 52/72 and 59/72 cases, respectively (P = 0.016). Cystoscopy missed 2 more invasive tumors than OCT-assisted cystoscopy. Cystoscopy (14.3%, 1/7) and OCT-assisted cystoscopy (28.6%, 2/7) showed relatively low sensitivity in detecting muscle invasion. Computer aided texture analysis demonstrated 75.1% sensitivity, 64.0% specificity, and 74.4% accuracy for differentiating tumor and normal urothelium.
OCT-assisted cystoscopy is a real time noninvasive and simple procedure that enhanced the accuracy of staging bladder tumors and prediction of any tumor invasion. Though the study did not meet the prespecified primary endpoint, OCT imaging is a promising adjunct to cystoscopy that may supplement intraoperative decision-making during transurethral resection of bladder tumors and additional prospective studies are warranted.
光学相干断层扫描（OCT）是一种新型成像方式，利用近红外光提供不同组织层的微观结构信息。这项前瞻性、多中心 II 期试验旨在评估 OCT 辅助膀胱镜检查在膀胱癌分期中的准确性。
纳入经门诊膀胱镜检查发现的原发性或复发性膀胱肿瘤（Ta、T1）患者。主要目的是评估 OCT 辅助膀胱镜检查确定组织病理学相关 T1 以上肿瘤分期的准确性和阳性预测值。63 例患者的 72 个可疑病变符合研究标准。所有疑似病变均通过常规膀胱镜检查进行评估，实时使用 OCT 进行解释，然后切除。所有结果均与病理结果进行比较。共获得 25 例患者 363 个肿瘤和正常黏膜 OCT 图像，以评估计算机辅助纹理分析算法的诊断效能。
对于预测浸润性肿瘤（≥T1，n=17），膀胱镜的敏感性和特异性分别为 58.8%和 92.7%，OCT 辅助膀胱镜检查的敏感性和特异性分别为 64.7%和 100%。膀胱镜和 OCT 辅助膀胱镜检查预测浸润性肿瘤的准确性分别为 84.7%和 91.7%（P=0.063）。膀胱镜和 OCT 辅助膀胱镜检查分别正确预测了 72 例中的 52 例和 59 例 T 分期（P=0.016）。膀胱镜检查比 OCT 辅助膀胱镜检查多漏诊了 2 例浸润性肿瘤。膀胱镜检查（14.3%，1/7）和 OCT 辅助膀胱镜检查（28.6%，2/7）在检测肌层浸润方面敏感性相对较低。计算机辅助纹理分析对区分肿瘤和正常尿路上皮的敏感性为 75.1%，特异性为 64.0%，准确性为 74.4%。
OCT 辅助膀胱镜检查是一种实时、非侵入性且简单的方法，可提高膀胱癌分期和任何肿瘤侵犯预测的准确性。尽管该研究未达到预设的主要终点，但 OCT 成像有望成为膀胱镜检查的辅助手段，可能在经尿道膀胱肿瘤切除术期间补充术中决策，并需要进一步开展前瞻性研究。
