Assistance in Neurosurgery (ExtempoRMN)

NCT ID: NCT02272452

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31

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.

Conditions

Primary Brain Tumor; Glioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy

Intervention Type: DEVICE

Other Intervention Names

HRMAS-NMR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Izzie Jacques Namer, MD

Role: STUDY_DIRECTOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre

Strasbourg, , France

Service de neurochirurgie

Strasbourg, , France

Service de Neurochirurgie

Strasbourg, , France

Countries

France

Central Contacts

Izzie Jacques Namer, MD

Role: CONTACT

Izzie.Jacques.NAMER@chru-strasbourg.fr

33.3.88.12.75.50

Facility Contacts

Izzie Jacques NAMER, MD

Role: primary

Izzie.Jacques.NAMER@chru-strasbourg.fr

33.3.88.12.75.50

Dominique CHAUSSEMY, MD

Role: primary

dominique.chaussemy@chru-strasbourg.fr

33.3.88.12.76.18

Robin SROUR

Role: primary

33.3.89.12.42.07

Other Identifiers

ExtempoRMN - RNI

Identifier Type: -

Identifier Source: org_study_id