Insights Into the Pathophysiology of Neurovascular Uncoupling in Patients with Brain Lesions.

NCT06797661 | Recruiting

• 1 other identifier: SRB2024304
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Neurovascular uncoupling (NVU) represents a major source of potential bias for the identification of eloquent brain regions through activation procedures in blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). Same region shows proper pattern in glucose metabolism in victiny of brain lesions, investigated with positron emitted tomography with radiolabeled glucose (PET-FDG) This research project aims at investigating the mechanisms of NVU by using a multimodal noninvasive imaging approach in neurosurgical patients.

Conditions

Glioblastoma; Glioma; Astrocytoma

Keywords

Primary brain tumor

Outcome Measures

Primary Outcomes (8)

• Effects of Hypercapnia administration on fMRI data

  For brain fRMI data: BOLD signal variation (Arbitrary Unit from a percent change from baseline).

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• Effects of Hypercapnia administration on PET-FDG regional standardized data.

  For brain PET-FDG: regional SUV value (Standardized Uptake Ratio) .The SUV is a mathematically derived ratio of tissue radioactivity concentration at a point in time at a specific region of interest and the injected dose of radioactivity per kilogram of the patient's body weight

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• Effects of Hypercapnia administration on PET-FDG global data

  For brain PET-FDG: Statistical Parametric Mapping analysis (SPM) for voxel-wise comparison and multiple correlations (t-score)

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• Effects of Hypercapnia administration on oxygen saturation (SpO2)

  SpO2 Variation: Measured in percentage points (%), reflecting the change from baseline levels.

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• End tidal CO2

  End Tidal CO2 during the experiment allow the modelisation and quantification of MRI signal among brain tissue. End tidal CO2 pressure is measured in mmHg

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• Breathing Rate

  Breathing Rate during the experiment allow the modelisation and quantification of MRI signal among brain tissue. Breathing rate is measure in respiration per minute

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• Regional Cerebral Blood Volume

  CBV represents the volume of blood present in 100 grams of brain tissue at a given time. It is used to assess the vascular capacity of the brain. unit are in mL per 100g of brain tissue .A DSC (Dynamic susceptibility contrast) -MRI is needed, the sequence involves the intravenous injection of a contrast agent, usually gadolinium-based. The contrast agent passes through the brain, and changes in the MRI signal are recorded over time.

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

• Regional Cerebral Blood Flow

  CBF measures the amount of blood flowing through 100 grams of brain tissue in one minute. This is a crucial measure for assessing cerebral perfusion and identifying areas of under- or hyperperfusion.(mL/100g/min)A DSC-MRI is needed, the sequence involves the intravenous injection of a contrast agent, usually gadolinium-based. The contrast agent passes through the brain, and changes in the MRI signal are recorded over time.

  end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)

Secondary Outcomes (5)

• Tumor Grading

  up to 2 week after last acquisition to allow Multidisciplinary oncologic commission to fix the grading status

• Tumor Histology

  up to 2 week after last acquisition to allow Multidisciplinary oncologic commission to fix the grading status

• Cerebrovascular reactivity mapping

  up to 1 month after the last acquisition to allow processing time , all the 40 patient together

• Correlation map

  up to 1 month after the last acquisition to allow processing time , all the 40 patient together

• Functional connectivity

  up to 1 month after the last acquisition to allow processing time , all the 40 patient together

Study Arms (1)

Glioma patient

EXPERIMENTAL

As compared to the pre-surgical evaluation that brain tumor patients routinely undergo in our institution, patients are asked to undergo some additional examinations.

Diagnostic Test: Functional MRI; Diagnostic Test: FDG-PET; Diagnostic Test: Structural MRI

Interventions

Functional MRI DIAGNOSTIC_TEST

11 minutes of Functional MRI alternating breathing Air-Room and gaz mix (5%CO2 21%O2 74%N2). All procedure are acquired simultaneously on a single acquisition on the PET/MRI camera in the institution.

Glioma patient

FDG-PET DIAGNOSTIC_TEST

Some patients who did not benefit from a FDG-PET in their clinical evaluation or more than 1 month before the inclusion in the present study will be ask to also undergo a brain FDG-PET , the dose is set at 2 Mega becquerel per Kg. All procedure are acquired simultaneously on a single acquisition on the PET/MRI camera in the institution.

Glioma patient

Structural MRI DIAGNOSTIC_TEST

Patient will benefit Different anatomical sequence of acquisition listed here : T1 , T1 with contrast agent (gadovist) , T2 flair , T2 and DSC (Dynamic susceptibility contrast) , and Time Of Flight . All procedure are acquired simultaneously on a single acquisition on the PET/MRI camera in the institution.

Glioma patient

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in the study include prior imaging showing a potentially resectable intra-cerebral mass lesion. Patient has to be included before surgery, chemotherapy and radiation

You may not qualify if:

• previous brain surgery
• respiratory failure
• Asthma
• Claustrophobia
• Previous adverse reaction to gadovist (contrast agent)
• Pregnancy and Breath feeding
• Diabetes (type I and II)

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

HUB-Erasme Hospital

Brussels, 1060, Belgium

RECRUITING

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MeSH Terms

Conditions

Glioblastoma; Glioma; Astrocytoma; Brain Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Xavier De Tiège, MD,PhD

  Laboratoire de Neuroanatomie et Neuroimagerie translationnelles Université Libre de Bruxelles

  STUDY CHAIR

Central Study Contacts

Thibault Vanbutsele

CONTACT

25558167; thibault.vanbutsele@hubruxelles.be

Study Design

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

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 28, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-01

Locations

BE (1)