Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02272452
Status:
UNKNOWN
Last Update Posted:
2014-10-23
First Post:
2014-10-15
Brief Title:
Assistance in Neurosurgery ExtempoRMN
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues ExtempoRMN
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExtempoRMN
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None