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| Name | Class |
|---|---|
| MEDIMPRINT | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProTool | Experimental | Device: Brain Tissue Imprint - Medical Device (ProTool) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Tissue Imprint - Medical Device (ProTool) | Device | genomic, transcriptomic and proteomic studies. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François BERGER, MD, PhD | Contact | francois.berger@inserm.fr | ||
| Clinical Research Department | Contact | ArcPromoteur@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| François BERGER, MD, PhD | University Grenoble Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Not yet recruiting | Angers | France |
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| Henri Mondor University Hospital | Not yet recruiting | Créteil | France |
|
| CLINATEC | Active, not recruiting | Grenoble | 38000 | France |
| Grenoble University Hospital | Recruiting | Grenoble | 38000 | France |
|
| Sainte-Anne Hospital | Not yet recruiting | Paris | 75000 | France |
|
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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