Intra-operative terahertz probe for breast cancer surgery

用于乳腺癌手术的术中太赫兹探头

• 批准号: TS/G001677/1
• 负责人: Arnie Purushotham
• 金额: $ 33.36万
• 依托单位: King's College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2008
• 资助国家: 英国
• 起止时间: 2008 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=TS%2FG001677%2F1
• 关键词: Intra; operative; terahertz; probe; breast

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)

本研究的目的是开发和评估一种临床就绪的手术探针，该探针使用太赫兹技术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，并在初步研究中被证明能够区分不同类型的乳腺组织。最初的研究是在一台平板太赫兹扫描仪上进行的（现在是TeraView的产品，Imaga 1000）。HTD项目的早期测试表明，术中探针可以很容易地在离体样本中区分肿瘤和正常组织，因此在手术室中使用它可以通过建立健康组织和病变组织之间的界限来指导外科医生。在HTD的赞助下，该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（以及与Imaga 1000进行性能评估）。Addenbrookes和Guys先前基于Imaga 1000的研究表明，基于使用支持向量机（SVM）处理太赫兹数据，太赫兹能够区分肿瘤和正常组织，灵敏度和特异性分别为92%和91%。目前的太赫兹项目由盖伊和圣托马斯研究伦理委员会批准（参考编号：07/Q0702/50）。拟议的项目有两个平行的方面：1)探测器的技术发展。这项活动本身分为3个方面：1)原型性能的改进：机械和光学；2)可用性和人体工程学。公司委托编写了一份独立报告，根据对潜在最终用户和医疗器械制造商的采访，帮助确定用户需求。设备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。这与目前的成本基础不一致，因此该设备开发计划的一个基本要素是我们采用更低成本的技术。其核心是采用成本较低的激光器（目前的激光器占当前工程成本的50%以上）。请注意，这不是在另一个激光产品上开槽的简单问题。激光的特性对系统的整体性能至关重要。为确定性能而进行的试验对第一架原型机的性能已经进行了初步研究。我们建议在这项工作的基础上，从离体试验开始，建立系统的敏感性和特异性。此后，当每次更新术中探针可用时，将进行重复的离体测试以重新建立性能。与此同时，将对患者进行体内试验，最终开发出的系统将进行为期一年的试验。拟议方案的关键里程碑是1。完成探针原型#1的离体试验/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）完成探针原型#2的离体测试（第11个月）引入具有临床人体工程学和用户界面的低成本设备（12个月前）新探头的体内研究完成（15月）完成低成本系统的体外研究（18月）完成新系统初始体内试验（第30个月）

项目成果

An intra-operative THz probe for use during the surgical removal of breast tumours

用于乳腺肿瘤手术切除的术中太赫兹探头

• 发表时间: 2008
• 作者: Michael Kontos

Use of terahertz pulsed imaging to differentiate malignant from normal breast tissue and lymph nodes

使用太赫兹脉冲成像区分恶性与正常乳腺组织和淋巴结

• 发表时间: 2010
• 作者: Paddy O'Kelly

Ex-vivo terahertz pulsed imaging to differentiate malignant from normal breast tissue

离体太赫兹脉冲成像可区分恶性和正常乳腺组织

• 发表时间: 2010
• 作者: Phil Ashworth

Terahertz pulsed imaging for margin ascertainment in breast conserving surgery

太赫兹脉冲成像用于保乳手术中的边缘确定

• 发表时间: 2009
• 作者: Paddy O'Kelly