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临床试验/NCT05010369
NCT05010369终止不适用

Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (In Vivo Phase)

University of Exeter2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
2
主要终点
Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra

研究概览

简要总结

Lymphoma diagnosis often involves removal and biopsy of one or more lymph nodes. Many (around half) of these diagnostic procedures show that no cancer is present, hence unnecessary removal results in numerous side effects and complications. The procedure is also highly invasive.

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when a low power laser is shone on to it. The investigators intend to use this technique, known as "Raman Spectroscopy" (RS) to tell if tissue in the node is cancerous or healthy. By combining RS with a fine needle, the technique can target tissues below the skin with minimal invasion. Our needle will provide the clinician with instant diagnosis without the delay and cost of a laboratory analysis by pathologists.

The investigators have designed a probe that slides through a fine needle, guided by ultrasound, to the lymph node. The space between the two needles provides space for cell aspirate.

The investigators propose to measure spectra from excess lymph node biopsy samples taken during standard routine diagnostic biopsy.

The investigators are also interested to see if they can successfully extract a fine needle aspiration (FNA) biopsy sample using the device, as well as record a RS measurement. If successful this would ease clinical adoption as the study could run in parallel with existing standard routine clinical practice, using just one device.

This study will evaluate the new device on half a lymph node that will be excised and snap-frozen during a routine surgical biopsy, to gather data for submission of approvals for an in-vivo study to follow.

详细描述

Surplus lymph node tissue collected from patients undergoing routine surgical treatment for head & neck disease will be investigated using vibrational spectroscopy.

The project will develop a combined FNA/Raman spectroscopy needle probe. This study will evaluate this device on excised lymph node tissue to gather data for submission of approvals for an in-vivo study to follow. Raman & FTIR (fourier transform infrared) spectra will be correlated with routine histopathology results using multivariate analysis methods. Cytology samples taken using the device will be compared with histopathology results.

Aims

To demonstrate that the FNA/Raman spectroscopy probe device, developed as part of this project, can:

Safely perform measurement of Raman spectra on excised lymph node tissue Safely perform FNA (fine needle aspiration) biopsies on excised lymph node tissue To evaluate the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing biopsy or excision of more than one lymph node as part of their routine clinical care within Gloucestershire Hospitals NHS Foundation Trust.
  • Patients undergoing lymphadenectomy as part of routine treatment

排除标准

  • Patients requiring biopsy of only one lymph node
  • Patients unable to consent to the study due to communication difficulties
  • Patients unable to consent to the study due to lack of capacity

结局指标

主要结局

Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra

时间窗: 3 years

Testing of the device for clinical application during surgery to demonstrate its use is safe and that is able to acquire diagnostic-quality spectra in less than 5 seconds from lymph nodes.

次要结局

  • Safe in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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