NCT07628257

Brief Summary

The aim of this study is to determine whether the diffuse cerebral metabolic disturbances observed in glioblastoma are exclusively linked to the direct and indirect effects of tumor infiltration (particularly structural disconnection), or whether they also reflect a more global alteration of neurometabolic and neurovascular coupling mechanisms. This approach thus aims to better understand the pathophysiological basis of cognitive impairment in glioblastoma and to characterize the impact of the disease at the level of brain networks.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2030

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

May 28, 2026

Last Update Submit

June 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between cortical energy activity (FDG PET), axonal morphological connectivity (DTI - MRI), synchronous neuronal activity (rs-fMRI), and preoperative neuropsychological performance before surgery

    Before surgery

Secondary Outcomes (1)

  • correlation between cortical energy activity (FDG PET), axonal morphological connectivity (DTI - MRI), synchronous neuronal activity (rs-fMRI), and preoperative neuropsychological performance after surgery

    After surgery, through the study, i.e. for a maximum of 2 years

Study Arms (1)

Patients with glioblastoma treated in the Department of Nuclear Medicine & Molecular Imaging

OTHER
Other: 18F-FDG PET/MRI with additional DTI and rs-fMRI sequences

Interventions

fluorodeoxyglucose (Fluor18) (18F-FDG) PET/MRI with additional DTI and rs-fMRI sequences correlation with neuropsychological tests

Patients with glioblastoma treated in the Department of Nuclear Medicine & Molecular Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Patients with glioblastoma
  • Patients treated in the Nuclear Medicine \& Molecular Imaging Department of the Strauss Institute for PET/MRI scans for:
  • Preoperative metabolic evaluation of a brain-expanding lesion

You may not qualify if:

  • Contraindications to MRI
  • Minor or incapacitated adult
  • Patient deprived of liberty
  • Patient under legal guardianship
  • Patient unable to consent
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut public de cancérologie Strauss Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Izzie-Jacques NAMER, MD, PhD

    Institut Public De Cancerologie Strauss Europe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

May 28, 2026

First Posted

June 4, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 15, 2030

Study Completion (Estimated)

September 15, 2030

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations