Assistance in Neurosurgery (ExtempoRMN)

• Conditions: Primary Brain Tumor; Glioma

• Registration Number: NCT02272452
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-22
• Last Update Submitted: 2014-10-22
• Study First Posted: 2014-10-23
• Last Update Posted: 2014-10-23
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Service de neurochirurgie; 🇫🇷 Strasbourg, France

Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Service de Neurochirurgie; 🇫🇷 Strasbourg, France