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

NCT07211841 | Not Yet Recruiting

• 1 other identifier: PI2024_843_0123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Glioblastoma; MRI spectroscopy; Tumor microenvironment; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (5)

• Variation from baseline of blood parameters

  at 1 month

• Progression-free survival

  at 12 months

• Overall survival

  at 12 months

• Correlation of biological and metabolomic data with progression-free survival

  at 12 months

• Correlation of biological and metabolomic data with overall survival

  at 12 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Antoine GALMICHE, PR

CONTACT

33+ 322087017; galmiche.antoine@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)