Swaan Abel, Mannaerts Christophe K, Scheltema Matthijs Jv, Nieuwenhuijzen Jakko A, Savci-Heijink C Dilara, de la Rosette Jean Jmch, van Moorselaar R Jeroen A, van Leeuwen Ton G, de Reijke Theo M, de Bruin Daniel Martijn
Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
Department of Biomedical Engineering and Physics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
JMIR Res Protoc. 2018 May 21;7(5):e132. doi: 10.2196/resprot.9813.
Focal therapy for prostate cancer has been proposed as an alternative treatment to whole-gland therapies in selected men to diminish side effects in localized prostate cancer. As nowadays imaging cannot offer complete prostate cancer disease characterization, multicore systematic biopsies are recommended (transrectal or transperineal). Optical imaging techniques such as confocal laser endomicroscopy and optical coherence tomography allow in vivo, high-resolution imaging. Moreover, they can provide real-time visualization and analysis of tissue and have the potential to offer additive diagnostic information.
This study has 2 separate primary objectives. The first is to assess the technical feasibility and safety of in vivo focal imaging with confocal laser endomicroscopy and optical coherence tomography. The second is to identify and define characteristics of prostate cancer and normal prostate tissue in confocal laser endomicroscopy and optical coherence tomography imaging by comparing these images with the corresponding histopathology.
In this prospective, in vivo feasibility study, needle-based confocal laser endomicroscopy and optical coherence tomography imaging will be performed before transperineal template mapping biopsy or radical prostatectomy. First, confocal laser endomicroscopy and optical coherence tomography will be performed in 4 patients (2 for each imaging modality) undergoing transperineal template mapping biopsy to assess the feasibility and safety of confocal laser endomicroscopy and optical coherence tomography. If proven to be safe and feasible, confocal laser endomicroscopy and optical coherence tomography will be performed in 10 patients (5 for each imaging modality) undergoing radical prostatectomy. Confocal laser endomicroscopy and optical coherence tomography images will be analyzed by independent, blinded observers. Confocal laser endomicroscopy- and optical coherence tomography-based qualitative and quantitative characteristics and histopathology will be compared. The study complies with the IDEAL (Idea, Development, Exploration, Assessment, Long-term study) stage 2a recommendations.
At present, the study is enrolling patients and results and outcomes are expected in 2019.
Confocal laser endomicroscopy and optical coherence tomography are promising optical imaging techniques that can visualize and analyze tissue structure, possible tumor grade, and architecture in real time. They can potentially provide real-time, high-resolution microscopic imaging and tissue characteristics of prostate cancer in conjunction with magnetic resonance imaging or transrectal ultrasound fusion-guided biopsy procedures. This study will provide insight into the feasibility and tissue-specific characteristics of confocal laser endomicroscopy and optical coherence tomography for real-time optical analysis of prostate cancer.
ClinicalTrials.gov NCT03253458; https://clinicaltrials.gov/ct2/show/NCT03253458 (Archived by WebCite at http://www.webcitation.org/6z9owM66B).
RR1-10.2196/9813.
对于局限性前列腺癌的特定患者，前列腺癌聚焦治疗已被提议作为全腺治疗的替代方案，以减少副作用。由于目前的成像技术无法对前列腺癌进行完整的疾病特征描述，因此建议进行多核心系统活检（经直肠或经会阴）。共聚焦激光内镜显微镜和光学相干断层扫描等光学成像技术可实现体内高分辨率成像。此外，它们能够提供组织的实时可视化和分析，并有可能提供额外的诊断信息。
本研究有两个独立的主要目的。第一个目的是评估共聚焦激光内镜显微镜和光学相干断层扫描进行体内聚焦成像的技术可行性和安全性。第二个目的是通过将共聚焦激光内镜显微镜和光学相干断层扫描图像与相应的组织病理学进行比较，识别并定义前列腺癌和正常前列腺组织在共聚焦激光内镜显微镜和光学相干断层扫描成像中的特征。
在这项前瞻性体内可行性研究中，将在经会阴模板引导穿刺活检或根治性前列腺切除术之前进行基于针的共聚焦激光内镜显微镜和光学相干断层扫描成像。首先，对4例接受经会阴模板引导穿刺活检的患者（每种成像方式2例）进行共聚焦激光内镜显微镜和光学相干断层扫描，以评估共聚焦激光内镜显微镜和光学相干断层扫描的可行性和安全性。如果证明安全可行，将对10例接受根治性前列腺切除术的患者（每种成像方式5例）进行共聚焦激光内镜显微镜和光学相干断层扫描。共聚焦激光内镜显微镜和光学相干断层扫描图像将由独立的、不知情的观察者进行分析。将比较基于共聚焦激光内镜显微镜和光学相干断层扫描的定性和定量特征与组织病理学。该研究符合IDEAL（构思、开发、探索、评估、长期研究）2a阶段的建议。
目前，该研究正在招募患者，预计2019年得出结果和成果。
共聚焦激光内镜显微镜和光学相干断层扫描是很有前景的光学成像技术，能够实时可视化和分析组织结构、可能的肿瘤分级和结构。它们有可能结合磁共振成像或经直肠超声融合引导活检程序，提供前列腺癌的实时、高分辨率微观成像和组织特征。本研究将深入了解共聚焦激光内镜显微镜和光学相干断层扫描用于前列腺癌实时光学分析的可行性和组织特异性特征。
ClinicalTrials.gov NCT03253458；https://clinicaltrials.gov/ct2/show/NCT03253458（由WebCite存档于http://www.webcitation.org/6z9owM66B）。
RR1-10.2196/9813。
