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

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ClinicalTrials.gov Identifier: NCT02077543
Recruitment Status : Recruiting
First Posted : March 4, 2014
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
MEDIMPRINT
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glioma : Oligodendroglioma or Astrocytoma Device: Brain Tissue Imprint - Medical Device (ProTool) Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
Study Start Date : October 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ProTool
Device: Brain Tissue Imprint - Medical Device (ProTool)
Device: Brain Tissue Imprint - Medical Device (ProTool)
genomic, transcriptomic and proteomic studies.




Primary Outcome Measures :
  1. Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma [ Time Frame: 2 hours after surgery ]
  2. Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma [ Time Frame: one month after surgery ]
  3. 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 Measures :
  1. Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis [ Time Frame: up to 1 month after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077543


Contacts
Contact: François BERGER, MD, PhD francois.berger@inserm.fr
Contact: Clinical Research Department ArcPromoteur@chu-grenoble.fr

Locations
France
Angers University Hospital Not yet recruiting
Angers, France
Contact: Philippe MENEI, MD, PhD         
Contact: Caroline , PhD       ArcPromoteur@chu-grenoble.fr   
Principal Investigator: Philippe MENEI, Pr         
Henri Mondor University Hospital Not yet recruiting
Creteil, France
Contact: Stéphane PALFI, MD, PhD         
Contact       ArcPromoteur@chu-grenoble.fr   
Principal Investigator: Stéphane PALFI, Pr         
CLINATEC Active, not recruiting
Grenoble, France, 38000
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: Emmanuel GAY, MD, PhD       EGay@chu-grenoble.fr   
Contact: , PhD       ArcPromoteur@chu-grenoble.fr   
Principal Investigator: Emmanuel GAY, Pr         
Principal Investigator: François BERGER, Pr         
Sainte-Anne Hospital Not yet recruiting
Paris, France, 75000
Contact: Bertrand DEVAUX, Pr         
Contact: , PhD       ArcPromoteur@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
MEDIMPRINT
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: François BERGER, MD, PhD University Grenoble Hospital

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02077543     History of Changes
Other Study ID Numbers: ProTool
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue