Clinical evaluation of a miniaturised cancer detection probe

癌症是英国主要的公共卫生挑战之一。每两分钟就有一个人被诊断出患有这种疾病。目前，英国每年因癌症造成的医疗费用和生产力损失达183亿英镑。据预测，到2020年，几乎一半的人口将在一生中被诊断出患有癌症，这对英国的健康和经济影响是相当大的。手术仍然是癌症患者的主要治疗选择之一，但往往是不成功的，很大程度上是由于不完全切除癌组织，或谨慎切除健康组织。手术经常失败，因为在手术过程中没有办法实时准确地检测癌症。外科医生完全依靠他们的肉眼和触觉来识别所有的癌组织。随着微创手术、锁眼手术和机器人手术的发展，外科医生现在甚至失去了使用触觉的能力，他们的视野也越来越受限制。许多技术都试图解决在手术中检测癌症的迫切医疗需求，但没有一种技术被证明足够准确和具有成本效益。该项目将迅速推进一种小型化的术中癌症检测探针EnLight的开发，该探针与微创锁眼手术和机器人手术系统完全兼容。该技术可能为术中癌症检测提供快速和高诊断性能。探测器的实验室概念验证已经完成。本项目将评估该技术在前列腺癌手术中检测癌症的临床效果，这是第一优先的癌症指征。最后，该项目将提供必要的临床数据，以建立安全性和性能，以帮助获得欧盟和美国监管机构的批准，以启动商业化和临床转化。

Cancer is one of the leading public health challenges in the UK. Someone is diagnosed with the disease every two minutes. Cancer currently costs the UK £18.3B per annum in healthcare expenses and lost productivity. With predictions that by 2020 almost half of the population will be diagnosed with cancer within their lifetime, the health and economic implications for the UK are considerable.Surgery remains one of the primary treatment options for cancer patients, but is very often unsuccessful, largely due to the incomplete removal of cancerous tissue, or the cautious excision of healthy tissue.Surgery often fails because there is no way to accurately detect cancer in real-time during surgery. Surgeons are completely dependent on their naked eye and sense of touch to identify all of the cancerous tissue. With the move towards minimally-invasive, key-hole and robotic surgery, surgeons have now even lost their ability to use their sense of touch and their field of view is increasingly restricted. Numerous technologies have attempted to address the pressing medical need to detect cancer during surgery but none have proven sufficiently accurate and cost-effective.This project will rapidly advance the development of a miniaturised intra-operative cancer detection probe, EnLight, which is fully compatible with minimally invasive key-hole surgery and robotic surgical systems. The technology potentially offers rapid and high diagnostic performance for intra-operative cancer detection. Laboratory proof-of-concept for the probe has been achieved. This project will evaluate the clinical effectiveness of the technology for detecting cancer during prostate cancer surgery, which is the first priority cancer indication. At the conclusion, this project will deliver the necessary clinical data to establish safety and performance to help secure regulatory approval in the EU and US to initiate commercialisation and clinical translation.