Intra-operative terahertz probe for breast cancer surgery

本研究的目的是开发和评估一种临床上准备好的手术探针，使用太赫兹技术来指导乳腺癌的手术切除。太赫兹技术能够区分正常组织和肿瘤，并在初步研究中显示能够区分不同类型的乳腺组织。初步研究是在平板THz扫描仪（现在是TeraView产品，Imaga 1000）上进行的。HTD项目期间的早期测试表明，术中探针可以很容易地区分肿瘤和离体样本中的正常组织，因此它在手术室中的使用将通过建立健康和患病组织之间的边界来指导外科医生。在HTD的赞助下，原型被用于收集和分析离体样本，与确定的组织病理学进行比较（以及评估与Imaga 1000的性能）。Addenbrookes和Guys先前基于Imaga 1000的研究证明了THz区分肿瘤和正常组织的能力，其灵敏度和特异性分别为92%和91%，基于使用支持向量机（SVM）处理太赫兹数据。目前的THz项目得到了Guy's & St托马斯研究伦理委员会的批准（参考编号：07/Q 0702/50）。拟议项目有两个平行的股1）探头的技术发展这项活动本身分为3个领域a）改进原型的性能：机械和光学B）可用性和人体工程学。该公司已委托独立的报告，帮助确定用户的要求，根据采访潜在的最终用户和医疗设备制造商。器械的最终可接受性主要取决于最终用户的反应，因此这是一个关键的工作包。c）生产设备的单位成本。该设备的市场预测是基于最终用户价格为10万美元。这与当前的成本基础不一致，因此，该器械开发计划的一个基本要素是我们采用较低成本的技术。其核心是采用成本较低的激光器（目前的激光器占目前工程成本的50%以上）。应当理解，这不是在另一激光产品中开槽的简单问题。激光器的特性对系统的整体性能至关重要。2)我们已经对第一个原型的性能进行了初步研究，我们建议在这项工作的基础上，从体外试验开始，建立系统的灵敏度和特异性。此后，当术中穿刺针的每次更新可用时，将重复进行体外试验以重新建立性能。与此同时，将在病人身上进行体内试验，最后对最终开发的系统进行为期一年的试验。完成探针原型#1的体外试验/建立初始灵敏度/特异性（第3个月）2.探头设计#2可用（第7个月）3.完成穿刺针原型#2的体外试验（第11个月）4.引入具有临床人体工程学和用户界面的低成本装置（到第12个月）5.完成新探头的体内研究（第15个月）6.完成低成本系统的体外研究（第18个月）7.完成新系统的初始体内试验（第30个月）

The objective of this study is to develop and evaluate a clinically-ready surgical probe that uses THz technology to guide the surgical excision of breast cancer. Terahertz technology is capable of distinguishing between normal tissue and tumour and has been shown to be able to distinguish different types of breast tissue in a preliminary study. Initial studies were carried out on a flat-bed THz scanner (now a TeraView product, Imaga 1000 ). Early tests during the HTD project indicate that an intra-operative probe can readily distinguish tumour from normal tissue in ex-vivo samples and so it's use in theatre will guide the surgeon by establishing the margins between healthy and diseased tissue. Under the HTD sponsorship, the prototype is being used to collect and analyse ex-vivo samples, to compare against definitive histopathology (as well as to assess performance against the Imaga 1000). Previous studies at Addenbrookes and Guys based on the Imaga 1000 demonstrated the ability of THz to differentiate tumour from normal tissue with sensitivity and specificity of 92% and 91% respectively, based on use of Support Vector Machine (SVM) processing of terahertz data. The current THz project was approved by the Guy's & St Thomas' Research Ethics Committee (Reference number: 07/Q0702/50). The proposed project has two parallel strands1) technical developments of the probeThis activity itself splits into 3 areasa) improvements in performance of the prototype : mechanical and optical b) usability and ergonomics. The Company has commissioned an independent report which has helped define user requirements, based on interviews with potential end users and medical device manufacturers. Ultimate acceptability of the device depends critically on end-user reaction and this is therefore a key work package. c) unit cost of production devices.Market projections for the device are based on an end-user price of 100k. This is not consistent with the current cost basis and hence an essential element of the exploitation plan for this device is that we incorporate lower cost technology. Central to this is the adoption of a lower cost laser (the current laser represents more than 50% of the current works cost). It will be appreciated that this is not a simple matter of slotting in another laser product. The characteristics of the laser are fundamental to the overall performance of the system. 2) tests, trials to establish performanceInitial studies of the performance of the first prototype have already been undertaken.We propose to build upon this work, starting with ex-vivo tests to establish system sensitivity and specificity. Thereafter, when each update to the intra-operative probe becomes available, repeat ex-vivo tests will be performed to re-establish performance. In parallel, in-vivo trials in patients will be performed culminating in a year-long trial of the final system developed.Key milestones of the proposed programme are 1. Complete ex-vivo tests of probe prototype #1 / establish initial sensitivity/specificity (Month 3)2. Probe design #2 available (Month 7)3. Complete ex-vivo tests of probe prototype #2 (Month 11)4. Introduction of lower cost unit with clinical ergonomics and user interface (by Month 12)5. Completion of in-vivo studies of new probe head (Month 15)6. Completion of ex-vivo studies of low cost system (Month 18)7. Completion of initial in-vivo trials of new system (Month 30)