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Assistance in Neurosurgery (ExtempoRMN) (ExtempoRMN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272452
Recruitment Status : Unknown
Verified October 2014 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

The main ambition of this project is to develop, and provide the medical community, an innovative method to analyze extemporaneously, during a neurosurgery operation, excised tissues. This method is based on the analysis of the metabolic profile of excised tissues by the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse (currently about 30 minutes but within our project a time lapse of 15 min or even less is ultimately intended), medical information that can complement those obtained by classic histological examination.

Primary purpose:

The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy in detecting residual tumor infiltration at the brain resection cavity. The investigators aim to determine the relevance of the metabolic analysis compared to histological analysis during a neurosurgery operation. This involves analyzing excised tissue samples, obtained from the operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center, with no return to neurosurgeon for surgery.

Secondary purposes:

The secondary objectives of the protocol are to investigate the metabolome of different types of brain tumors, in order to find prognostic and diagnostic markers. It consists in detecting metabolomic factors of bad prognosis, and potential marker of good prognosis such as the IDH mutation.


Condition or disease Intervention/treatment
Primary Brain Tumor Glioma Device: High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy
    Other Name: HRMAS-NMR


Primary Outcome Measures :
  1. The percentage of the cases for which, the HRMAS NMR spectroscopy results of the excised tissues are consistent with quantitative histological analysis of the same excised tissues. [ Time Frame: 3 years from the beginning of the study ]
    To validate the primary endpoint of this study, statistical analysis should confirm this consistency in at least 95% of the cases.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Under the " ExtempoRMN "project, we propose to focus on primary brain tumors mainly gliomas that include: Glioblastomas, the low-grade oligodendrogliomas (WHO grade II) and high grade (WHO grade III), Astrocytomas. Normality will be obtained by analysis of control brain tissues from epilepsy surgery. Study population for this project is all the patients of department of neurosurgery of Strasbourg University Hospitals and Colmar Hospital center, for whom a neurosurgical operation is programmed before inclusion in this study, and who meets inclusion criteria.
Criteria

Inclusion criteria:

  • Male or female
  • Age 18 years of age or older at the time of surgery
  • Primary brain tumors (gliomas mainly) or epilepsy, for which neurosurgical intervention is programmed
  • In the case of brain tumors: primary-lesions or transformation of low-grade gliomas into high-grade gliomas not treated with radiotherapy
  • Affiliated with a social security
  • Having signed the informed consent
  • Having been informed of the results of the medical examination prior

Exclusion criteria:

  • Relapse of tumors previously treated with radiotherapy or chemotherapy
  • Subject under treatment (radiotherapy or chemotherapy) prior to surgery
  • Metastatic lesions (location of the primary lesion outside the central nervous system)
  • Inability to give to the subject or his/her family enlightened information (subject in emergency situation, difficulties of understanding...)
  • Subject under judicial protection
  • Subject under guardianship or curatorship
  • Patients' Refusal

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): NCT02272452


Contacts
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Contact: Izzie Jacques Namer, MD 33.3.88.12.75.50 Izzie.Jacques.NAMER@chru-strasbourg.fr

Locations
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France
Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre
Strasbourg, France
Contact: Izzie Jacques NAMER, MD    33.3.88.12.75.50    Izzie.Jacques.NAMER@chru-strasbourg.fr   
Service de neurochirurgie
Strasbourg, France
Contact: Dominique CHAUSSEMY, MD    33.3.88.12.76.18    dominique.chaussemy@chru-strasbourg.fr   
Service de Neurochirurgie
Strasbourg, France
Contact: Robin SROUR    33.3.89.12.42.07      
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Izzie Jacques Namer, MD Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02272452    
Other Study ID Numbers: ExtempoRMN - RNI
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014
Keywords provided by University Hospital, Strasbourg, France:
High resolution magic angle spinning Nuclear magnetic resonance
Nuclear magnetic resonance
Spectroscopy
Primary brain tumors
Gliomas
extemporaneous analysis
Additional relevant MeSH terms:
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Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases