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

NCT ID: NCT07211841

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-04-30

Brief 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. 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.

Conditions

Glioblastoma; MRI Spectroscopy; Tumor Microenvironment; Biomarkers / Blood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

MRS study

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.

Intervention Type: DEVICE

blood samples

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Countries

France

Central Contacts

Antoine GALMICHE, PR

Role: CONTACT

galmiche.antoine@chu-amiens.fr

33+ 322087017

Facility Contacts

Antoine Galmiche, Pr

Role: primary

Other Identifiers

PI2024_843_0123

Identifier Type: -

Identifier Source: org_study_id