Evaluation of the Predictive Value of 18F-fluorodeoxyglucose Positron Emission Tomography and Brain Perfusion Computed Tomography for the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Recurrent Glioblastoma

Study Overview
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Brief Summary
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In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.

Official Title
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Evaluation of the Value of 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET) and Brain Perfusion Computed Tomography (CT Perfusion) for Predicting the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Patients With Recurrent Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Other: FDG PET
* Other: CT scan
* Other: Magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient has an WHO score ≤ 3 The patient's estimated life expectancy is more than 3 months. Patient with histologically proven diagnosis of glioblastoma. Patient presenting with tumor progression on morphological MRI confirmed by a multidisciplinary committee. Patient with a unilateral supratentorial target lesion upon inclusion to establish a tumor region of interest (ROI) zone and an equivalent ROI zone in contralateral healthy tissue. Patient progressing after radiotherapy and at least one line of chemotherapy with TEMODAL Patient in whom treatment with Bevacizumab monotherapy has been validated by a multidisciplinary committee. Exclusion Criteria: The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study The subject refuses to sign the consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship Pregnant or breast feeding patients Hypersensitivity to iodinated contrast media and creatinine clearance less than 60 ml / minute.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with recurrent glioblastoma<br> | Other: FDG PET<br>* IV application of F Dopa, 2 MBq per Kg, with a scout view (angle of view 90 °, 120 kV, 30 mAs), then an X-ray scan is performed for the attenuation correction ( 120 kV - 5mAs - pitch 0.531 - thickness // increment: 3.75mm//3.27mm -QAC filter - DFOV 25). PET acquisition: static in 3D mode for 20 minutes, 8 minutes after the injection of 18 F Dopa, the axial field of view is 25, the matrix in 256 x 256. After OSEM reconstruction 6 iterations and 24 subsets, with correction of attenuation and diffusion, then Gaussian filter of frequency 4, 47 contiguous axial sections of 3.26 mm are obtained.<br>Other: CT scan<br>* Localization propeller without injection: 120kV - mA regulation (Noise Index 15) - pitch 0.969 - thickness // increment: 5mm // 5mm - Soft filter - Asir 60% - DFOV 25. Acquisition begins 5 seconds after the start of the injection of 60 ml of contrast product (VISIPAQUE) at 4 cc / second without (acquisition characteristics: 80 kV - 100 mAs -- thickness: 5mm // 8 images / rotation - STD filter - Asir 50% display field of view (DFOV) 25 - phase1: 5s then phase2 15s). Diagnostic quality CT: 120kV - Regulation of mA (Noise Index 15) - pitch 0.531 - thickness // increment: 1.25 // 0.625mm - Soft filter - Asir 60% - DFOV 25.<br>Other: Magnetic resonance imaging (MRI)<br>* If the examination is performed on the SIEMENS SKYRA 3T device: 32 channel head coil antenna, if on the PHILIPPS INGENIA 1.5 T device: DStream HeadSpine Coil antenna. The sequence begins with an axial, coronal and sagittal Survey topogram, lasting 1 minute. Then axial sequence T1, Axial T2 *, Axial cerebral perfusion (Injection of gadolinium (0.1 mmol / kg, 5 cc / second), coronal T2, Axial T2 Flair, Axial DWI b100, Axial 3D T1 gadolinium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorization of patients as responders or non-responders to treatment | Measured by MRI according to Response Assessment in Neuro-Oncology (RANO) criteria: Complete response/Partial response/stable/progression | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Tumor Volume | FDG PET | Day 0 | 
| Metabolic Tumor Volume | FDG PET | Day 14 | 
| Fixation Index | Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata | Day 0 | 
| Fixation Index | Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata | Day 14 | 
| permeability-surface area product | CT scan | Day 0 | 
| permeability-surface area product | CT scan | Day 14 | 
| cerebral blood flow | CT scan | Day 0 | 
| cerebral blood flow | CT scan | Day 14 | 
| Normalized permeability-surface area product to healthy brain | CT scan | Day 0 | 
| Normalized permeability-surface area product to healthy brain | CT scan | Day 14 | 
| Normalized cerebral blood flow to healthy brain | CT scan | Day 0 | 
| Normalized cerebral blood flow to healthy brain | CT scan | Day 14 | 
| Inter-rater reproducibility of FDG PET | LIN intraclass correlation coefficient | End of study (September 2022) | 
| Inter-rater reproducibility of CT scan | LIN intraclass correlation coefficient | End of study (September 2022) |