GliomaGLIOMRSNCT05700071
MRS of Glioma Genomics
A study testing MRI in people with Glioma, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial summary
In France, about 5000 new people with a primary malignant brain tumor are diagnosed each year. The most common primary tumors are gliomas, originating from glial cells (astrocytomas and oligodendrogliomas). Low-grade gliomas are mildly aggressive, but they often evolve into a more malignant form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Mar 2023to 2 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Affiliations to a social security scheme (as a beneficiary or a person entitled to benefits)
- Obtainig written, informed consent
- One of the following two situations
- Group 1 : Probable grade II/III/IV glioma, for which excision is scheduled.
- Group 2 : Histologically confirmed grade II or III glioma with known IDH1/IDH2 status, which has received no treatment other than surgery and is due to undergo therapy other than surgery.
- Presence of measurable tumor residue (>2 cm in diameter on FLAIR imaging)
- Karnofsky Index > 60
- Effective contraception throughout the study, supplemented by a negative pregnancy test for women of childbearing age.
Who cannot join
- Containdications to MRI : Pacemaker or neural stimulators, intraocular or intracerebral metallic foreign bodies, cochlear implant, heart valve or metallic surgical arterial devices that are not MRI ompatible, metallic devices susceptible to concentrating radio-frequency pulses, claustrophobia
- Pregnant or breastfeeding women
- Regulatory criteria :
- Pregnant women, women in labor, breastfeeding women ; Failure to sign the consent form or paticipant refusal ; Legal protection measures (guardianship, curatorship, judicial protection) ; Participation in another research study that does not allow for compliance with the exclusion period between the two studies ; Individuals not covered by a health insurance scheme.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Pitié-Salpetrière Hospital
Paris, 75013
Marc Sanson, MD, PhD, (0)1 42 16 03 91 ext. 0033, marc.sanson@aphp.fr
- Recruiting
Hôpital Pitié Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris
Paris, Île-de-France Region, 75013
Marc Sanson, pr, 01 42 16 03 91, marc.sanson@aphp.fr
About this study
Official title: Magnetic Resonance Spectroscopy Markers of Glioma Genomics
In France, about 5000 new people with a primary malignant brain tumor are diagnosed each year. The most common primary tumors are gliomas, originating from glial cells (astrocytomas and oligodendrogliomas). Low-grade gliomas are mildly aggressive, but they often evolve into a more malignant form.
Mutations in the genes encoding isocitrate dehydrogenase (IDH) are found in about 80% of low-grade gliomas and are associated with a favorable prognosis. Remarkably, IDH-mutated gliomas are characterized by a specific cellular metabolism causing the accumulation of D-2-hydroxyglutarate (2HG) in tumor cells. 2HG can be detected in vivo using 1H magnetic resonance spectroscopy (MRS) and is recognized as a unique, noninvasive biomarker of IDH-mutated gliomas. Noninvasive detection of IDH mutations via 2HG MRS represents a crucial step for decision-making and patient care.
Read more
A subset of IDH-mutated tumors also presents a complete deletion of 1p and 19q chromosome arms (1p/19q codeletion). The 1p/19q codeletion is specifically linked to the oligodendroglial histologic subtype and it has been associated with a better patient outcome. However, the biological effects of this genetic alteration are still unclear and in vivo markers are lacking. Recently, we reported the first in vivo detection of the cystathionine molecule in human brain gliomas using MRS and explored the association between cystathionine accumulation and 1p/19q codeletion in gliomas.
In this project, the investigation team will combine cutting edge MRI and MRS techniques for metabolic and microstructural characterization of brain tumors with the aim of providing novel reliable noninvasive biomarkers of tumor genetic subtypes. These methods will enable noninvasive identification of IDH-mutated gliomas and, potentially, 1p/19q codeleted gliomas. In addition, the researchers will investigate the utility of 2HG, cystathionine and MRI microstructural markers to monitor tumor response to anti-cancer treatments and tumor progression.
The outputs of this project, altogether, may open new avenues to a better understanding of the pathophysiological mechanisms of oncogenesis and the design of new treatments for gliomas.
- Conditions
- Glioma
- Being tested
- MRI
- Keywords
- Gliomas, Isocitrate dehydrogenase, 1p19q codeletion, MR Spectroscopy, MRI, Diagnosis, Treatment monitoring
- Medical subject headings
- Glioma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI without contrast agent
| Study group | Role | What they receive |
|---|---|---|
| MRI examination | Experimental | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite concentrations by MRS
Concentrations of 2-hydroxyglutarate and cystahionine measured by MRS will be correlated with IDH mutational status and 1p19q codeletion derived from ex vivo analyses in tumor tissue samples
Measured: 1.5 hour
Secondary outcomes (3)
Diffusion MRI metrics
Diffusion MRI metrics will be correlated with the 1p19q codeletion status derived from ex vivo analyses in tumor tissue samples
Measured: 1,5 hours
Metabolic changes during an anti-tumor treatment
The changes in concentration of 2-hydroxyglutarate, cystathionine and choline will be compared to the changes in tumor volumes and to the clinical response
Measured: 1 year
Diffusion MRI and amide proton transfer signal changes during an anti-tumor treatment.
Diffusion MRI and amide proton transfer signal changes will be compared to the changes in metabolism, tumor volumes and to the clinical response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start6 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion2 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Francesca Branzoli, PhD, Study director, Paris Brain Institute, Paris, FranceMarc Sanson, MD, PhD, Principal investigator, Paris Brain Institute, AP-HP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700071
- Sponsor's protocol ID
- C21-27
- Other IDs
- 2021-A03015-36
- Acronym
- GLIOMRS
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopy Markers of Glioma Genomics
- ClinicalTrials.gov ID
- NCT05700071
- Acronym / sponsor ID
- GLIOMRS / C21-27
- Conditions
- Glioma
- Keywords
- Gliomas, Isocitrate dehydrogenase, 1p19q codeletion, MR Spectroscopy, MRI, Diagnosis, Treatment monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 2 Mar 2028 (estimated)
- First posted
- 26 Jan 2023 (actual)
- 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.
In France, about 5000 new people with a primary malignant brain tumor are diagnosed each year. The most common primary tumors are gliomas, originating from glial cells (astrocytomas and oligodendrogliomas). Low-grade gliomas are mildly aggressive, but they often evolve into a more malignant form.
Mutations in the genes encoding isocitrate dehydrogenase (IDH) are found in about 80% of low-grade gliomas and are associated with a favorable prognosis. Remarkably, IDH-mutated gliomas are characterized by a specific cellular metabolism causing the accumulation of D-2-hydroxyglutarate (2HG) in tumor cells. 2HG can be detected in vivo using 1H magnetic resonance spectroscopy (MRS) and is recognized as a unique, noninvasive biomarker of IDH-mutated gliomas. Noninvasive detection of IDH mutations via 2HG MRS represents a crucial step for decision-making and patient care.
A subset of IDH-mutated tumors also presents a complete deletion of 1p and 19q chromosome arms (1p/19q codeletion). The 1p/19q codeletion is specifically linked to the oligodendroglial histologic subtype and it has been associated with a better patient outcome. However, the biological effects of this genetic alteration are still unclear and in vivo markers are lacking. Recently, we reported the first in vivo detection of the cystathionine molecule in human brain gliomas using MRS and explored the association between cystathionine accumulation and 1p/19q codeletion in gliomas.
In this project, the investigation team will combine cutting edge MRI and MRS techniques for metabolic and microstructural characterization of brain tumors with the aim of providing novel reliable noninvasive biomarkers of tumor genetic subtypes. These methods will enable noninvasive identification of IDH-mutated gliomas and, potentially, 1p/19q codeleted gliomas. In addition, the researchers will investigate the utility of 2HG, cystathionine and MRI microstructural markers to monitor tumor response to anti-cancer treatments and tumor progression.
The outputs of this project, altogether, may open new avenues to a better understanding of the pathophysiological mechanisms of oncogenesis and the design of new treatments for gliomas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI examination | Experimental | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Affiliations to a social security scheme (as a beneficiary or a person entitled to benefits)
- Obtainig written, informed consent
- One of the following two situations
- Presence of measurable tumor residue (>2 cm in diameter on FLAIR imaging)
- Karnofsky Index > 60
Key exclusion criteria (4 listed)
- Containdications to MRI : Pacemaker or neural stimulators, intraocular or intracerebral metallic foreign bodies, cochlear implant, heart valve or metallic surgical arterial devices that are not MRI ompatible, metallic devices susceptible to concentrating radio-frequency pulses, claustrophobia
- Pregnant or breastfeeding women
- Regulatory criteria :
- Pregnant women, women in labor, breastfeeding women ; Failure to sign the consent form or paticipant refusal ; Legal protection measures (guardianship, curatorship, judicial protection) ; Participation in another research study that does not allow for compliance with the exclusion period between the two studies ; Individuals not covered by a health insurance scheme.
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 |
|---|---|---|
| MRIMRI without contrast agent | Diagnostic test | MRI examination |
Primary outcome
Metabolite concentrations by MRS
Time frame: 1.5 hour
Concentrations of 2-hydroxyglutarate and cystahionine measured by MRS will be correlated with IDH mutational status and 1p19q codeletion derived from ex vivo analyses in tumor tissue samples
3 secondary outcomes
Diffusion MRI metrics
Time frame: 1,5 hours
Metabolic changes during an anti-tumor treatment
Time frame: 1 year
Diffusion MRI and amide proton transfer signal changes during an anti-tumor treatment.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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.
Francesca Branzoli, PhD study director
Paris Brain Institute, Paris, France
Marc Sanson, MD, PhD principal investigator
Paris Brain Institute, AP-HP, Paris, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Glioma, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Sanson, MD, PhD ((0)1 42 16 03 91 ext. 0033, marc.sanson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolite concentrations by MRS (time frame: 1.5 hour). 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 8 Jul 2026.