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)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Glioblastoma

Treatments: Other: CT scan; Other: Magnetic resonance imaging (MRI); Other: FDG PET

Study type: Interventional

Funder types: Other

Identifiers

NCT04566185

NIMAO/2018-03/LC-01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

Patients with recurrent glioblastoma

Experimental group

Treatment:

Other: FDG PET

Other: Magnetic resonance imaging (MRI)

Other: CT scan