Assistance in Neurosurgery (ExtempoRMN) (ExtempoRMN)

October 22, 2014 updated by: University Hospital, Strasbourg, France

Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Strasbourg, France
    - Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre
  - Strasbourg, France
    - Service de Neurochirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years from the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

Study Director: Izzie Jacques Namer, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Estimate)