Assistance in Neurosurgery (ExtempoRMN) (ExtempoRMN)
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|ClinicalTrials.gov Identifier: NCT02272452|
Recruitment Status : Unknown
Verified October 2014 by University Hospital, Strasbourg, France.
Recruitment status was: Not yet recruiting
First Posted : October 23, 2014
Last Update Posted : October 23, 2014
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.
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.
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|
|Primary Brain Tumor Glioma||Device: High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2017|
- Device: High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy
Other Name: HRMAS-NMR
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272452
|Contact: Izzie Jacques Namer, MD||188.8.131.52.75.50||Izzie.Jacques.NAMER@chru-strasbourg.fr|
|Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre|
|Contact: Izzie Jacques NAMER, MD 184.108.40.206.75.50 Izzie.Jacques.NAMER@chru-strasbourg.fr|
|Service de neurochirurgie|
|Contact: Dominique CHAUSSEMY, MD 220.127.116.11.76.18 email@example.com|
|Service de Neurochirurgie|
|Contact: Robin SROUR 18.104.22.168.42.07|
|Study Director:||Izzie Jacques Namer, MD||Hôpitaux Universitaires de Strasbourg|