Primary Brain TumorExtempoRMNNCT02272452
Assistance in Neurosurgery (ExtempoRMN)
An observational study of Primary Brain Tumor and Glioma, run by University Hospital, Strasbourg, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Brain Tumor, Glioma
- What is being tested?
- High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2014to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Under the " ExtempoRMN "project, we propose to focus on primary brain tumors mainly gliomas that include: Glioblastomas, the low-grade oligodendrogliomas (WHO grade II) and high grade (WHO grade III), Astrocytomas. Normality will be obtained by analysis of control brain tissues from epilepsy surgery. Study population for this project is all the patients of department of neurosurgery of Strasbourg University Hospitals and Colmar Hospital center, for whom a neurosurgical operation is programmed before inclusion in this study, and who meets inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre
Strasbourg
Izzie Jacques NAMER, MD, 33.3.88.12.75.50, Izzie.Jacques.NAMER@chru-strasbourg.fr
Service de neurochirurgie
Strasbourg
Dominique CHAUSSEMY, MD, 33.3.88.12.76.18, dominique.chaussemy@chru-strasbourg.fr
Service de Neurochirurgie
Strasbourg
Robin SROUR, 33.3.89.12.42.07
About this study
Official title: Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)
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:
Read more
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
- Being tested
- High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy
- Keywords
- High resolution magic angle spinning Nuclear magnetic resonance, Nuclear magnetic resonance, Spectroscopy, Primary brain tumors, Gliomas, extemporaneous analysis
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopyDevice
Also called HRMAS-NMR
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izzie Jacques Namer, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272452
- Sponsor's protocol ID
- ExtempoRMN - RNI
- Acronym
- ExtempoRMN
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)
- ClinicalTrials.gov ID
- NCT02272452
- Acronym / sponsor ID
- ExtempoRMN / ExtempoRMN - RNI
- Conditions
- Primary Brain Tumor, Glioma
- Keywords
- High resolution magic angle spinning Nuclear magnetic resonance, Nuclear magnetic resonance, Spectroscopy, Primary brain tumors, Gliomas, extemporaneous analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Under the " ExtempoRMN "project, we propose to focus on primary brain tumors mainly gliomas that include: Glioblastomas, the low-grade oligodendrogliomas (WHO grade II) and high grade (WHO grade III), Astrocytomas. Normality will be obtained by analysis of control brain tissues from epilepsy surgery. Study population for this project is all the patients of department of neurosurgery of Strasbourg University Hospitals and Colmar Hospital center, for whom a neurosurgical operation is programmed before inclusion in this study, and who meets inclusion criteria.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopyAlso: HRMAS-NMR | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Izzie Jacques Namer, MD study director
Hôpitaux Universitaires de Strasbourg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brain Tumor and Glioma, run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Izzie Jacques Namer, MD (33.3.88.12.75.50, Izzie.Jacques.NAMER@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2014.