Clinical trial NCT04566185: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Categorization of patients as responders or non-responders to treatment
timeFrame: 2 months
Secondary outcomes:
measure: Metabolic Tumor Volume
timeFrame: Day 0
measure: Metabolic Tumor Volume
timeFrame: Day 14
measure: Fixation Index
timeFrame: Day 0
measure: Fixation Index
timeFrame: Day 14
measure: permeability-surface area product
timeFrame: Day 0
measure: permeability-surface area product
timeFrame: Day 14
measure: cerebral blood flow
timeFrame: Day 0
measure: cerebral blood flow
timeFrame: Day 14
measure: Normalized permeability-surface area product to healthy brain
timeFrame: Day 0
measure: Normalized permeability-surface area product to healthy brain
timeFrame: Day 14
measure: Normalized cerebral blood flow to healthy brain
timeFrame: Day 0
measure: Normalized cerebral blood flow to healthy brain
timeFrame: Day 14
measure: Inter-rater reproducibility of FDG PET
timeFrame: End of study (September 2022)
measure: Inter-rater reproducibility of CT scan
timeFrame: End of study (September 2022)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Laurent Collombier
role: PRINCIPAL_INVESTIGATOR
References: