Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma (IMAGLIO)

Toulouse University Hospital

Status: Terminated

Conditions: Glioblastoma

Treatments: Other: Clinical examination; Drug: Bevacizumab; Drug: F-MISO; Other: Cerebral magnetic resonance imagery

Study type: Interventional

Funder types: Other

Identifiers

NCT02841332

12 050 03

Details and patient eligibility

About

The purpose of this study is to estimate the capacity of the multimodal imaging parameters measured at 15 days and 2 months of initiation of treatment with bevacizumab, to measure changes in clinical status (sensitivity to measure changes) in patients treated for recurrent glioblastoma.

Full description

Glioblastomas are tumors with poor prognosis. The treatment of recurrent glioblastoma after a standard first-line treatment is not clearly codified, however, many results in the literature show the benefit of bevacizumab (anti- angiogenic therapy) and it is often proposed in this indication . Tissue action, response mechanisms and therapeutic escape remain is poorly understood.

The investigators hypothesize that these response mechanisms are controlled by changes in some parameters in the tumor tissue, such as hypoxia, neoangiogenesis, cell density and that multimodal imaging can help us to better understand these mechanisms.

To identify which parameters of imaging would best measure response mechanisms, the investigators want to evaluate in the first study and for this particular indication , a property of the measure called by the Anglo -Saxon ' sensitivity to change " that is to say, its sensitivity or ability to measure changes. This is an additional property to the reproducibility of the measurement.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• World Health Organization performance index lower or equal to 3
• Estimated life expectancy greater than 3 months
• patient in whom the diagnosis of glioblastoma was histologically proven
• Patient with tumor progression of morphological magnetic resonance imagery evidenced by Pluri Disciplinary Meeting. This increase must meet the detailed criteria Response Assessment Neuro Oncology Working group : except in the case of a new lesion appearing outside of the field of radiotherapy, tumor progression can not therefore be defined on an magnetic resonance imagery performed in a period shorter than 12 weeks after the last day of radiotherapy (see criteria Response Assessment Neuro Oncology Working Group detailed chapter 2-1 B)
• Patient with unilateral tensor above injury at baseline (in order to have in each case a tumor region of interest area and an area equivalent region of interest contralateral healthy tissue) .
• Patient with measurable lesion at baseline, according to the criteria defined by the working group Respons Assessment Neuro Oncology. The lesion with contrast is measured two-dimensionally on T1 gadolinium in axial section. The two perpendicular diameters of red lead should be 10 mm and that at least two axial sections.
• Patient with progression after radiotherapy and have received at least one chemotherapy regimen (temodal)
• A patient in whom treatment with bevacizumab monotherapy

Exclusion criteria

• Pregnancy
• Exclusion criteria related to cons to the realization of positron emission tomography or magnetic resonance imagery : Weight greater than 120 kg, Foreign body incompatible with magnetic resonance imagery (eg metallic intraocular foreign body), Medical equipment installed incompatible with magnetic resonance imagery (eg pacemaker)
• Pregnant or lactating woman

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Patients with glioblastoma

Experimental group

Description:

Patient with histologically proved glioblastoma diagnostic will receive the following interventions : * Cerebral magnetic resonance imagery * Tomography emission positron with F-MISO * Bevacizumab administration * Clinical examination

Treatment:

Drug: F-MISO

Other: Cerebral magnetic resonance imagery

Drug: Bevacizumab

Other: Clinical examination