Olde Heuvel Judith, de Wit-van der Veen Berlinda J, van der Poel Henk G, Bekers Elise M, Grootendorst Maarten R, Vyas Kunal N, Slump Cornelis H, Stokkel Marcel P M
Department of Nuclear Medicine, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Technical Medicine Center, University of Twente, Enschede, Netherlands.
Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2624-2632. doi: 10.1007/s00259-020-04783-1. Epub 2020 Apr 2.
Currently, approximately 11-38% of prostate cancer (PCa) patients undergoing radical prostatectomy have a positive surgical margin (PSM) on histopathology. Cerenkov luminescence imaging (CLI) using Ga-prostate-specific membrane antigen (Ga-PSMA) is a novel technique for intraoperative margin assessment. The aim of this first-in-man study was to investigate the feasibility of intraoperative Ga-PSMA CLI. In this study, feasibility was defined as the ability to distinguish between a positive and negative surgical margin, imaging within 45 min and low radiation exposure to staff.
Six patients were included in this ongoing study. Following perioperative i.v. injection of ~ 100 MBq Ga-PSMA, the prostate was excised and immediately imaged ex vivo. Different acquisition protocols were tested, and hotspots on CLI images from the intact prostate were marked for comparison with histopathology.
By using an acquisition protocol with 150 s exposure time, 8 × 8 binning and a 550 nm shortpass filter, PSMs and negative surgical margins (NSMs) were visually correctly identified on CLI in 3 of the 5 patients. Two patients had a hotspot on CLI from cancer < 0.1 mm from the excision margin.
Overall, the study showed that Ga-PSMA CLI is a feasible and low-risk technique for intraoperative margin assessment in PCa. The remaining patients in this ongoing study will be used to assess the diagnostic accuracy of the technique.
NL8256 registered at www.trialregister.nl on 04/11/20109.
目前，接受根治性前列腺切除术的前列腺癌（PCa）患者中，约11%-38%在组织病理学检查时存在手术切缘阳性（PSM）。使用镓标记的前列腺特异性膜抗原（Ga-PSMA）的切伦科夫发光成像（CLI）是一种用于术中切缘评估的新技术。这项首例人体研究的目的是调查术中Ga-PSMA CLI的可行性。在本研究中，可行性定义为区分手术切缘阳性和阴性的能力、45分钟内成像以及对工作人员的低辐射暴露。
本项正在进行的研究纳入了6例患者。围手术期静脉注射约 100 MBq Ga-PSMA后，切除前列腺并立即进行离体成像。测试了不同的采集方案，并标记了完整前列腺CLI图像上的热点，以便与组织病理学结果进行比较。
通过使用曝光时间为150秒、8×8像素合并和550纳米短波通滤光片的采集方案，5例患者中有3例在CLI上通过视觉正确识别了PSM和阴性手术切缘（NSM）。2例患者的CLI图像上，距切除边缘<0.1毫米处有来自癌组织的热点。
总体而言，该研究表明Ga-PSMA CLI是一种用于PCa术中切缘评估的可行且低风险的技术。本项正在进行的研究中的其余患者将用于评估该技术的诊断准确性。
于2010年11月4日在www.trialregister.nl上注册，注册号为NL8256 。
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