Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma

Early Phase 1

• Conditions: Glioma : Oligodendroglioma or Astrocytoma
• Interventions: Device: Brain Tissue Imprint - Medical Device (ProTool)

• Registration Number: NCT02077543
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ProTool	Brain Tissue Imprint - Medical Device (ProTool)	Device: Brain Tissue Imprint - Medical Device (ProTool)

Primary Outcome Measures

Name	Time	Method
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma	3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis	up to 1 month after surgery

Trial Locations

Locations (5)

Angers University Hospital; 🇫🇷 Angers, France

Henri Mondor University Hospital; 🇫🇷 Creteil, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

CLINATEC; 🇫🇷 Grenoble, France

Sainte-Anne Hospital; 🇫🇷 Paris, France