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

ConditionsGlioblastomaGliomaAstrocytoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

previous brain surgery

respiratory failure

Asthma

Claustrophobia

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Glioma patientExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Effects of Hypercapnia administration on fMRI data

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

Time frame
end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)
2

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

Time frame
end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)
3

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)

Time frame
end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)
4

Effects of Hypercapnia administration on oxygen saturation (SpO2)

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

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

Secondary outcomes

1

Tumor Grading

Tumor Grading, respectively with the World Health Organisation (WHO) 2021 guideline about brain neoplasm

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

Tumor Histology

respectively with the WHO 2021 guideline about brain neoplasm from the surgery clinically planned

Time frame
up to 2 week after last acquisition to allow Multidisciplinary oncologic commission to fix the grading status
3

Cerebrovascular reactivity mapping

Integration of the variation in fMRI signal and end tidal CO2, and breathing rate into a quantification . The produced data are in % of MRI signal change per mmHg of CO2

Time frame
up to 1 month after the last acquisition to allow processing time , all the 40 patient together
4

Correlation map

Correlation on coregistration of fMRI and PET procedure among the brain and plotted in a linear regression. Correlation will be expressed in Spearman's "R".

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasme University Hospital

Lead sponsor

Source ClinicalTrials.gov
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