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临床试验/NCT06306118
NCT06306118招募中不适用

Application of the Autoguide® Positioning Device for Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Biopsy Results

研究概览

简要总结

The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.

The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.

On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.

To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision.

详细描述

Operations involving positioning of needles and catheters are amongst the most common procedures in cranial neurosurgery. One of the most important matters that have to be considered is that, submillimetric (<0.1 mm) precision is essential for the success of these procedures. However, many biopsy needle procedures for obtaining tissue specimens are currently performed with limited accuracy, i.e. using a mechanical arm. This could potentially lead to procedural failure such as inconclusive tissue sampling and even major complications, e.g. cerebral hemorrhage with consecutive neurologic deficits.

Therefore, navigation-guidance was implemented and established over the last two decades. Using preoperatively compiled anatomical patient data from radiological images (Computerized Tomography [CT] or Magnetic Resonance Imaging [MRI] scans) a trajectory from entry to target point can be defined and matched intraoperatively on the patient's head.

In case of stereotactic needle biopsies, inaccuracy is associated with the acquisition of non-diagnostic samples in up to 24% of stereotactic biopsy series or non-representative tumor samples in up to 64% of biopsies. Therefore, serial biopsies could be performed to overcome this drawback - associated with an increased risk of intracranial hemorrhages, which have been reported in 0.3 - 59.8% of the cases and contribute considerably to the reported morbidity of 0-16.1% of this procedure.

The Autoguide® system is a modular guidance system for surgical invasive tools which provides a precise, submillimetric trajectory alignment according to the predefined navigation data.

After the development of this miniaturized robotic guidance system for neurosurgery was successfully finalized, AutoGuide®, a robot for clinical application in neurosurgery, is now commercially available from the Medtronic company.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years
  • Diagnosis of a cerebral lesion with the indication for surgical resection
  • Written informed consent to participate in the present study
  • MRI and CT scanner compatibility

排除标准

  • Pregnancy, breast feeding
  • Patients not able to reason
  • Age <18 or >80 years
  • Claustrophobia

结局指标

主要结局

Biopsy Results

时间窗: 30 minutes to 1 hour (frozen section procedure)

histopathological results (according to the WHO classification of CNS tumours) of the multiple biopsies will be matched with the results of the main tumor specimen

次要结局

未报告次要终点

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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