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NCT Number: NCT07211841

Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Location contact

Antoine Galmiche, Pr

CONTACT

Ismail NAJJAR, MD

SUB_INVESTIGATOR

Jean-Marc CONSTANS CONSTANS, Pr

SUB_INVESTIGATOR

Mathieu Boone, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • minor patients,
  • pregnant/lactating women,
  • patients under guardianship,
  • curatorship,
  • protection of justice or deprived of liberty

Treatment and study plan

MRS study

Device

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 samples

Biological

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Variation from baseline of blood parameters

    Time frame: at 1 month

    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).

  2. Progression-free survival

    Time frame: at 12 months

  3. Overall survival

    Time frame: at 12 months

  4. Correlation of biological and metabolomic data with progression-free survival

    Time frame: at 12 months

    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. Correlation of biological and metabolomic data with overall survival

    Time frame: at 12 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine GALMICHE, PR

CONTACT

[email protected]

33+ 322087017

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: GLIOMIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 8, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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