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临床试验/NCT01012154
NCT01012154Unknown1 期

In Vivo Confocal Microscopy Tumor Atlas Study

Carl Zeiss Surgical GmbH2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
150
试验地点
2
主要终点
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.

研究概览

简要总结

This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site-matched biopsies.

详细描述

Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.

In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy

排除标准

  • History of allergy to fluorescein
  • Patients on beta-blockers or ACE inhibitors
  • Pregnant women
  • Inability to give informed consent

结局指标

主要结局

Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.

时间窗: During surgery

次要结局

  • Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.(One week)
  • Capture usability and workflow aspects for the confocal device.(During surgery)

研究者

发起方
Carl Zeiss Surgical GmbH
申办方类型
Industry

研究点 (2)

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