Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma (ProTool)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
150 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Clinical Research Department; François BERGER, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal