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

Glioblastoma Clinical Trial

— EVA DOPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566185
• Other study ID #: NIMAO/2018-03/LC-01
• Status: Recruiting
• Start date: December 16, 2020
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Laurent Collombier
• Phone: 04.66.68.32.49
• Email: laurent.collombier[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Other:
• FDG 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.
• CT 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.
• Magnetic 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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Metabolic Tumor Volume	FDG PET	Day 0
Secondary	Metabolic Tumor Volume	FDG PET	Day 14
Secondary	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
Secondary	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
Secondary	permeability-surface area product	CT scan	Day 0
Secondary	permeability-surface area product	CT scan	Day 14
Secondary	cerebral blood flow	CT scan	Day 0
Secondary	cerebral blood flow	CT scan	Day 14
Secondary	Normalized permeability-surface area product to healthy brain	CT scan	Day 0
Secondary	Normalized permeability-surface area product to healthy brain	CT scan	Day 14
Secondary	Normalized cerebral blood flow to healthy brain	CT scan	Day 0
Secondary	Normalized cerebral blood flow to healthy brain	CT scan	Day 14
Secondary	Inter-rater reproducibility of FDG PET	LIN intraclass correlation coefficient	End of study (September 2022)
Secondary	Inter-rater reproducibility of CT scan	LIN intraclass correlation coefficient	End of study (September 2022)