Glioblastoma
Conditions
Brief summary
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.
Interventions
OTHERFDG PET
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.
OTHERCT scan
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.
OTHERMagnetic resonance imaging (MRI)
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
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Categorization of patients as responders or non-responders to treatment | 2 months | Measured by MRI according to Response Assessment in Neuro-Oncology (RANO) criteria: Complete response/Partial response/stable/progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fixation Index | Day 0 | Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata |
| permeability-surface area product | Day 0 | CT scan |
| cerebral blood flow | Day 0 | CT scan |
| Metabolic Tumor Volume | Day 0 | FDG PET |
| Normalized cerebral blood flow to healthy brain | Day 0 | CT scan |
| Inter-rater reproducibility of FDG PET | End of study (September 2022) | LIN intraclass correlation coefficient |
| Inter-rater reproducibility of CT scan | End of study (September 2022) | LIN intraclass correlation coefficient |
| Normalized permeability-surface area product to healthy brain | Day 0 | CT scan |
Countries
France
Outcome results
None listed