Clinical trial NCT02272452: Assistance in Neurosurgery (ExtempoRMN)
Official title: Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Brain Tumor
Glioma
Keywords: High resolution magic angle spinning Nuclear magnetic resonance
Nuclear magnetic resonance
Spectroscopy
Primary brain tumors
Gliomas
extemporaneous analysis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 3 years from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre
city: Strasbourg
country: France
facility: Service de neurochirurgie
city: Strasbourg
country: France
facility: Service de Neurochirurgie
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Izzie Jacques Namer, MD
role: STUDY_DIRECTOR
References: