Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
研究概览
简要总结
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
详细描述
Current limitations in the management of high grade brain tumors partly reside in the lack of access to pathological tissue.
Conventional biopsy devices can cause severe side effects, thus limiting the amount of tissue that can be collected for molecular characterization. The Brain-Tissue-Imprint Devices evaluated in this trial offers a unique opportunity to perform multiple non-lesion sampling in both tumor tissue and peritumoral areas. The approach relies on the use of tailored silicon chips integrated in surgical devices enabling tissue sampling through a brief "silicon to tissue contact", thus limiting potential side effects, and opening a way to extensive molecular investigation of brain tumors and their microenvironment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more or equal than 18 years old
- •patient affiliated to social security or similarly regime
- •informed consent form signed
- •glial tumor suspicion
- •Stereotaxic biopsy indication
- •Karnofsky score > 70%
- •Hematological assessment :
- •neutrophils > 1500/mm3
- •Platelet > 150 000
- •blood Creatinin normal
- •alkaline Phosphatases and transaminases no more than two times normal
- •Bilirubin < 1.5 times normal
排除标准
- •Pregnant women and lactating mothers
- •Ward of court or under guardianship
- •Adult unable to express their consent
- •Person deprived of freedom by judicial or administrative decision
- •Person hospitalized without their consent
- •Person under legal protection
- •Person participating in another clinical study
- •Intratumoral hemorrhage MRI detected
- •Treatment anticoagulant or antisludge treatments
- •Active Infections and non controled or medical affection or psychiatric intercurrent non treated
- •Evolutive cerebral oedema without corticoid response
- •Non controled Epilepsy without antiepileptics response
- •Susceptibility to Medical Device materials allergy
结局指标
主要结局
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
时间窗: 3 months after surgery
次要结局
- Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis(up to 1 month after surgery)