Clinical trial NCT02077543: Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
Official title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glioma : Oligodendroglioma or Astrocytoma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: MEDIMPRINT
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-03-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
timeFrame: 2 hours after surgery
measure: Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
timeFrame: one month after surgery
measure: Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
timeFrame: up to 1 month after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Creteil
country: France
facility: Henri Mondor University Hospital
city: Grenoble
country: France
facility: CLINATEC
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Paris
country: France
facility: Sainte-Anne Hospital
Study officials:
affiliation: University Grenoble Hospital
name: François BERGER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: