Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma

Study Overview
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Brief Summary
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The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.

Detailed Description
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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.

Official Title
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Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors

Conditions
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Glioma : Oligodendroglioma or Astrocytoma

Intervention / Treatment
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* Device: Brain Tissue Imprint - Medical Device (ProTool)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProTool<br>Device: Brain Tissue Imprint - Medical Device (ProTool) | Device: Brain Tissue Imprint - Medical Device (ProTool)<br>* genomic, transcriptomic and proteomic studies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma |  | 2 hours after surgery | 
| Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma |  | one month after surgery | 
| Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis |  | up to 1 month after surgery |