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

Glioma : Oligodendroglioma or Astrocytoma Clinical Trial

— ProTool  

Official title:

Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02077543
• Other study ID #: ProTool
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 2013
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: François BERGER, MD, PhD
• Email: francois.berger[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Glioma
• Glioma : Oligodendroglioma or Astrocytoma
• Oligodendroglioma

Intervention

Device:
• Brain Tissue Imprint - Medical Device (ProTool)
genomic, transcriptomic and proteomic studies.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Henri Mondor University Hospital	Creteil
France	CLINATEC	Grenoble
France	Grenoble University Hospital	Grenoble
France	Sainte-Anne Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France, MEDIMPRINT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma		2 hours after surgery
Primary	Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma		one month after surgery
Primary	Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma		3 months after surgery
Secondary	Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis		up to 1 month after surgery