An Early Phase 1 interventional study of Brain Tissue Imprint - Medical Device (ProTool) in Glioma : Oligodendroglioma or Astrocytoma, sponsored by University Hospital, Grenoble. Status unknown at 5 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University Hospital, Grenoble · Early Phase 1, Interventional, and Diagnostic
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.
434 studies on the registry are indexed under Astrocytoma; 79 are open to participants now.
This study's planned enrollment of 150 is above the median of 30 across 359 interventional studies indexed under Astrocytoma.
Browse Astrocytoma studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
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Device: Brain Tissue Imprint - Medical Device (ProTool)
Device: Brain Tissue Imprint - Medical Device (ProTool)
genomic, transcriptomic and proteomic studies.
Clinical 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
The record gives a start of Oct 2013, a primary completion of Jun 2020 and a completion of Dec 2020. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble →