Assistance in Neurosurgery (ExtempoRMN)

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02272452

Collaborator

(none)

1,000

Enrollment

Locations

333.3

Patients Per Site

Study Details

Study Description

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	Phase
Primary Brain Tumor Glioma	Device: High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy

Study Design

Study Type:

Observational

Anticipated 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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2017

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre	Strasbourg	France
2	Service de neurochirurgie	Strasbourg	France
3	Service de Neurochirurgie	Strasbourg	France