Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma (ProTool)
Primary Purpose
Glioma : Oligodendroglioma or Astrocytoma
Status
Unknown status
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Brain Tissue Imprint - Medical Device (ProTool)
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioma : Oligodendroglioma or Astrocytoma
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
Sites / Locations
- Angers University Hospital
- Henri Mondor University Hospital
- CLINATEC
- Grenoble University HospitalRecruiting
- Sainte-Anne Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ProTool
Arm Description
Device: Brain Tissue Imprint - Medical Device (ProTool)
Outcomes
Primary Outcome Measures
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Secondary Outcome Measures
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
Full Information
NCT ID
NCT02077543
First Posted
October 10, 2013
Last Updated
March 24, 2020
Sponsor
University Hospital, Grenoble
Collaborators
MEDIMPRINT, Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02077543
Brief Title
Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
Acronym
ProTool
Official Title
Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
MEDIMPRINT, Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma : Oligodendroglioma or Astrocytoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ProTool
Arm Type
Experimental
Arm Description
Device: Brain Tissue Imprint - Medical Device (ProTool)
Intervention Type
Device
Intervention Name(s)
Brain Tissue Imprint - Medical Device (ProTool)
Intervention Description
genomic, transcriptomic and proteomic studies.
Primary Outcome Measure Information:
Title
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time Frame
2 hours after surgery
Title
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time Frame
one month after surgery
Title
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
Time Frame
up to 1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François BERGER, MD, PhD
Email
francois.berger@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Department
Email
ArcPromoteur@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François BERGER, MD, PhD
Organizational Affiliation
University Grenoble Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers University Hospital
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MENEI, MD, PhD
First Name & Middle Initial & Last Name & Degree
Caroline, PhD
Email
ArcPromoteur@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Philippe MENEI, Pr
Facility Name
Henri Mondor University Hospital
City
Creteil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane PALFI, MD, PhD
Email
ArcPromoteur@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Stéphane PALFI, Pr
Facility Name
CLINATEC
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel GAY, MD, PhD
Email
EGay@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
PhD
Email
ArcPromoteur@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel GAY, Pr
First Name & Middle Initial & Last Name & Degree
François BERGER, Pr
Facility Name
Sainte-Anne Hospital
City
Paris
ZIP/Postal Code
75000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand DEVAUX, Pr
First Name & Middle Initial & Last Name & Degree
PhD
Email
ArcPromoteur@chu-grenoble.fr
12. IPD Sharing Statement
Learn more about this trial
Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
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