跳至主要内容
临床试验/NCT03482622
NCT03482622Unknown不适用

Accurate Assessment of Tumour Clearance During Surgical Treatment of Basal Cell Carcinoma by Fast Raman Spectroscopy

University of Nottingham0 个研究点目标入组 600 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
主要终点
Validity

研究概览

简要总结

The main objective of this research is to develop a new scanning technology called the Fast Raman device, to accurately check the skin removed by the surgeon and detect any residual cancer cells; if found, additional skin can then be removed by surgeons on the same day. The device will be tested first for patients undergoing Mohs micrographic surgery, then be extended to wide-local excisions of basal cell carcinoma (BCC). This study will determine the validity (sensitivity/specificity) and reliability (inter- and intra-user variability) of the Fast Raman device for checking the completeness of tumour removal during Mohs micrographic surgery of BCC.

详细描述

Raman spectroscopy (RS) is an established analytical technique and has been extensively used in medicine to study individual cells and complex tissues, including skin and skin cancers. This technique is based on inelastic scattering of laser light following its interaction with vibrating molecules of biological samples; therefore, a Raman spectrum represents a "chemical fingerprint" of the sample. Recently, the investigators demonstrated that Raman micro-spectroscopy is able to discriminate between healthy skin and BCC.

With National Institute for Health Research (NIHR) i4i funding (2007-2013), the investigators developed a new technology ("Fast Raman") that can detect BCC regions in skin layers excised during Mohs surgery [13]. A first laboratory prototype based on this technology was able to analyze specimens in 30-60 minutes. In a follow-up i4i project (2014-2016), the investigators have built a fully automated "Fast Raman" device that can be used by non-specialist users and meets the safety requirements to be used in the clinic. The investigators now intend to test this device in real clinical practice and to compare the diagnosis generated by the device with the standard pathology diagnosis.

If the performance of the device achieves the proposed target (~95% sensitivity and specificity, inter-and intra-user reliability higher than typical histopathology, assessment time shorter than frozen section histopathology), it will provide important benefit to BCC patients and health care providers. Faster tissue assessment could speed up Mohs surgery (around 90 mins rather than 3 hours), which is more comfortable for patients. By reducing the costly histopathology procedures needed to process and diagnose skin samples, the Fast Raman device will reduce health care costs, allowing Mohs surgery to become more widely available, and reducing the postcode lottery that currently exists. As the Fast Raman device is designed to be used by non-specialist user, it can be used during any type of BCC surgery, including standard wide local excisions of BCC (>80,000 procedures/year in UK), to provide on the spot an answer on whether the entire tumour has been excised or not.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing Mohs micrographic surgery of BCC.
  • Able to give informed consent.

排除标准

  • Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.

结局指标

主要结局

Validity

时间窗: Immediate

Accuracy (sensitivity/specificity) of diagnosis made by the Fast Raman device compared to frozen-section histopathology (standard practice) as a the standard of reference.

次要结局

  • Measurement Time(Immediate)
  • Reliability(Immediate)

研究者

申办方类型
Other
责任方
Sponsor

相似试验