GlioblastomaGLIOMITNCT07211841
Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)
A study testing MRS study and blood samples in people with Glioblastoma and MRI Spectroscopy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Glioblastoma multiforme (GBM) is the most common primary brain tumor, and it is well-known to be associated with a poor prognosis. MRI is the key medical technique for the diagnosis and the follow-up of GBM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, MRI Spectroscopy, Tumor Microenvironment
- What is being tested?
- MRS study and blood samples
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2025to Apr 2029
- 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
- Patients consecutively identified in the multidisciplinary consultation meeting of neurooncology with a new diagnosis of GBM / a probable diagnosis of GBM. - Patients that have not started radiochemotherapy ;
- Adult > 18 yrs
- socially-insured,
- having given consent.
Who cannot join
- minor patients,
- pregnant/lactating women,
- patients under guardianship,
- curatorship,
- protection of justice or deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Glioblastoma multiforme (GBM) is the most common primary brain tumor, and it is well-known to be associated with a poor prognosis. MRI is the key medical technique for the diagnosis and the follow-up of GBM. By allowing for MRS studies, MRI permits a non-invasive characterization of the TME of GBM, including their metabolic characterization. The investigators propose to address the link between the MRS profile of GBM and basic clinical and biological parameters, with the aim of : i) identifying correlations between these parameters, ii) attempting to integrate clinical, biological and spectroscopic profiles of GBM. The investigators plan to recruit 30 newly diagnosed GBM patients for which surgery / radiochemotherapy will be proposed in the Medical oncology unit of Amiens University Hospital. Following inclusion of patients with probable GBM, MRS study will be performed during the first (pre-therapeutic) MRI examination. Basic clinical and biological parameters of the blood (CRP, complete blood count, fibrinogen, lactate and choline) will be assessed. A metabolomic study will also be performed on the plasma of GBM patients before any therapeutics. A second biological, post-therapeutic assesment (one month after surgery/radiochemotherapy) will allow the same analyses (basic biological parameters + plasma metabolomics), in order to examine the stability of the blood parameters.
- Being tested
- MRS study, blood samples
- Keywords
- Glioblastoma, MRI spectroscopy, Tumor microenvironment, biomarkers
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRS studyDevice
Thirty patients newly diagnosed with GBM will be included in this study. The study will be conducted without any major modification of the standard management of GBM.
The MRS study will be performed at the time of the initial MRI examination (morphological MRI sequences performed on 3T Philipps). The MRS will be performed on the most agressive part of the tumor : monovoxel PRESS MRS sequence with 3 echo times : 35, 144 and 288 ms. Spectra processing with Philipps software returns relative quantifications > 7 ratios (choline/creatin, Glucose/creatin, glutamine/creatin, N-Acetyl aspartate/creatin, myoinositol/creatin, phsopholipids/creatin, lactate/creatin, acetate/creatin). With this experimental design, the additional time required for MRS acquisition is 10 min /patient.
blood samplesBiological
Routine basic clinical and biological analyses will be collected during the project. In addition, 2 blood samples (5 mL each time) will be obtained at the time of inclusion (pre-therapeutic) and one month after completion of the initial therapeutic cycle (surgery + radiochemotherapy). The plasma samples will be used to measure fibrinogen, lactate and choline concentrations. In addition, a metabolomic study of plasma will be performed w
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between initial spectroscopic parameters, basic clinical and biological informations
correlations between initial spectroscopic parameters of the tumor, basic clinical information and biological assessment of the blood in a cohort of newly-diagnosed GBM
Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
Measured: 12 months
Secondary outcomes (5)
Variation from baseline of blood parameters
Variation from baseline of blood parameters at one month after surgery/radiochemotherapy in each patient. Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
Measured: at 1 month
Progression-free survival
Measured: at 12 months
Overall survival
Measured: at 12 months
Correlation of biological and metabolomic data with progression-free survival
Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
Measured: at 12 months
Correlation of biological and metabolomic data with overall survival
Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study startDec 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211841
- Sponsor's protocol ID
- PI2024_843_0123
- Acronym
- GLIOMIT
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT07211841
- Acronym / sponsor ID
- GLIOMIT / PI2024_843_0123
- Keywords
- Glioblastoma, MRI spectroscopy, Tumor microenvironment, biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 8 Oct 2025 (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.
Glioblastoma multiforme (GBM) is the most common primary brain tumor, and it is well-known to be associated with a poor prognosis. MRI is the key medical technique for the diagnosis and the follow-up of GBM. By allowing for MRS studies, MRI permits a non-invasive characterization of the TME of GBM, including their metabolic characterization. The investigators propose to address the link between the MRS profile of GBM and basic clinical and biological parameters, with the aim of : i) identifying correlations between these parameters, ii) attempting to integrate clinical, biological and spectroscopic profiles of GBM. The investigators plan to recruit 30 newly diagnosed GBM patients for which surgery / radiochemotherapy will be proposed in the Medical oncology unit of Amiens University Hospital. Following inclusion of patients with probable GBM, MRS study will be performed during the first (pre-therapeutic) MRI examination. Basic clinical and biological parameters of the blood (CRP, complete blood count, fibrinogen, lactate and choline) will be assessed. A metabolomic study will also be performed on the plasma of GBM patients before any therapeutics. A second biological, post-therapeutic assesment (one month after surgery/radiochemotherapy) will allow the same analyses (basic biological parameters + plasma metabolomics), in order to examine the stability of the blood parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients consecutively identified in the multidisciplinary consultation meeting of neurooncology with a new diagnosis of GBM / a probable diagnosis of GBM. - Patients that have not started radiochemotherapy ;
- Adult > 18 yrs
- socially-insured,
- having given consent.
Key exclusion criteria (5 listed)
- minor patients,
- pregnant/lactating women,
- patients under guardianship,
- curatorship,
- protection of justice or deprived of liberty
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 |
|---|---|---|
| MRS studyThirty patients newly diagnosed with GBM will be included in this study. The study will be conducted without any major modification of the standard management of GBM. The MRS study will be performed at the time of the initial MRI examination (morphological MRI sequences performed on 3T Philipps). The MRS will be performed on the most agressive part of the tumor : monovoxel PRESS MRS sequence with 3 echo times : 35, 144 and 288 ms. Spectra processing with Philipps software returns relative quantifications > 7 ratios (choline/creatin, Glucose/creatin, glutamine/creatin, N-Acetyl aspartate/creatin, myoinositol/creatin, phsopholipids/creatin, lactate/creatin, acetate/creatin). With this experimental design, the additional time required for MRS acquisition is 10 min /patient. | Device | – |
| blood samplesRoutine basic clinical and biological analyses will be collected during the project. In addition, 2 blood samples (5 mL each time) will be obtained at the time of inclusion (pre-therapeutic) and one month after completion of the initial therapeutic cycle (surgery + radiochemotherapy). The plasma samples will be used to measure fibrinogen, lactate and choline concentrations. In addition, a metabolomic study of plasma will be performed w | Biological | – |
Primary outcome
Correlations between initial spectroscopic parameters, basic clinical and biological informations
Time frame: 12 months
correlations between initial spectroscopic parameters of the tumor, basic clinical information and biological assessment of the blood in a cohort of newly-diagnosed GBM Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
5 secondary outcomes
Variation from baseline of blood parameters
Time frame: at 1 month
Progression-free survival
Time frame: at 12 months
Overall survival
Time frame: at 12 months
Correlation of biological and metabolomic data with progression-free survival
Time frame: at 12 months
Correlation of biological and metabolomic data with overall survival
Time frame: at 12 months
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRS study and blood samples in people with Glioblastoma and MRI Spectroscopy, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Antoine GALMICHE, PR (33+ 322087017, galmiche.antoine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between initial spectroscopic parameters, basic clinical and biological informations (time frame: 12 months). 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 19 Nov 2025.