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

• Conditions: Glioblastoma
• Interventions: Other: FDG PET; Other: CT scan; Other: Magnetic resonance imaging (MRI)

• Registration Number: NCT04566185
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2020-12-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with recurrent glioblastoma	CT scan	-
Patients with recurrent glioblastoma	FDG PET	-
Patients with recurrent glioblastoma	Magnetic resonance imaging (MRI)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France