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 (EVA DOPA)

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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Other: FDG PET; Other: CT scan; Other: Magnetic resonance imaging (MRI)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

The study population consists of patients with recurrent glioblastoma for whom the initiation of treatment with Bevacizumab is decided by the Neuro-oncology mulitdisciplinary committee at the Nîmes University Hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with recurrent glioblastoma

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.; Other: 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.; Other: 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Collombier, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: NIMAO/2018-03/LC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No