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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
genomic, transcriptomic and proteomic studies.
Angers University Hospital
Angers, France
NOT_YET_RECRUITINGHenri Mondor University Hospital
Créteil, France
NOT_YET_RECRUITINGCLINATEC
Grenoble, France
ACTIVE_NOT_RECRUITINGClinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time frame: 2 hours after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time frame: one month after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time frame: 3 months after surgery
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
Time frame: up to 1 month after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Grenoble University Hospital
Grenoble, France
Sainte-Anne Hospital
Paris, France
NOT_YET_RECRUITING