Glioma : Oligodendroglioma or Astrocytoma
Conditions
Brief summary
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
Detailed description
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.
Interventions
DEVICEBrain Tissue Imprint - Medical Device (ProTool)
genomic, transcriptomic and proteomic studies.
Sponsors
MEDIMPRINT
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma | 2 hours after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis | up to 1 month after surgery |
Countries
France
Contacts
Primary ContactFrançois BERGER, MD, PhD
Backup ContactClinical Research Department
Outcome results
None listed