Assistance in Neurosurgery (ExtempoRMN)

Glioma Clinical Trial

— ExtempoRMN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02272452
• Other study ID #: ExtempoRMN - RNI
• Status: Not yet recruiting
• Phase: N/A
• First received: October 15, 2014
• Last updated: October 22, 2014
• Start date: October 2014

Study information

• Verified date: October 2014
• Source: University Hospital, Strasbourg, France
• Contact: Izzie Jacques Namer, MD
• Phone: 33.3.88.12.75.50
• Email: Izzie.Jacques.NAMER[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma
• Primary Brain Tumor

Intervention

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

Locations

Country	Name	City	State
France	Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre	Strasbourg
France	Service de neurochirurgie	Strasbourg
France	Service de Neurochirurgie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No