Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma

NCT ID: NCT02841332

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

Detailed 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.

Conditions

Glioblastoma

Keywords

Recurrent Glioblastoma; Positron emission tomography; Fluoro misonidazole; MRI multimodal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with glioblastoma

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

Group Type: EXPERIMENTAL

F-MISO

Intervention Type: DRUG

The fluoro-misonidazole is a positron emission tomography tracer (labeled with Fluorine-18)-specific hypoxia. This compound penetrates into cells where it is reduced by a nitroreductase enzyme. It is rapidly regenerated by reoxidation when the cell is properly oxygenated. This metabolite can accumulate in viable hypoxic cells (necrotic cells that can provide initial reduction reaction of F-MISO).

Moreover, the fixing of this tracer appears to be independent of blood flow. The advantage of this technique is to provide a direct image of hypoxic cells by directly targeting under stress hypoxic.

Cerebral magnetic resonance imagery

Intervention Type: OTHER

During the pre-therapeutic imagery session :

• Morphological magnetic resonance imagery ( axial T1 sequence axial T1 post contrast , Flair Axial )
• magnetic resonance imagery spectroscopy sequence
• Perfusion magnetic resonance imagery sequence
• Diffusion magnetic resonance imagery sequence

Bevacizumab

Intervention Type: DRUG

Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)

Clinical examination

Intervention Type: OTHER

During the examination, the following parameters will be checked :

• Neurological examination
• Corticotherapy prescribed
• General status of patient (world health organization score)
• Weight and height
• Control of arterial pressure
• Chirurgical and medical history
• Concomitant treatment

Interventions

F-MISO

The fluoro-misonidazole is a positron emission tomography tracer (labeled with Fluorine-18)-specific hypoxia. This compound penetrates into cells where it is reduced by a nitroreductase enzyme. It is rapidly regenerated by reoxidation when the cell is properly oxygenated. This metabolite can accumulate in viable hypoxic cells (necrotic cells that can provide initial reduction reaction of F-MISO).

Moreover, the fixing of this tracer appears to be independent of blood flow. The advantage of this technique is to provide a direct image of hypoxic cells by directly targeting under stress hypoxic.

Intervention Type: DRUG

Cerebral magnetic resonance imagery

During the pre-therapeutic imagery session :

• Morphological magnetic resonance imagery ( axial T1 sequence axial T1 post contrast , Flair Axial )
• magnetic resonance imagery spectroscopy sequence
• Perfusion magnetic resonance imagery sequence
• Diffusion magnetic resonance imagery sequence

Intervention Type: OTHER

Bevacizumab

Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)

Intervention Type: DRUG

Clinical examination

During the examination, the following parameters will be checked :

• Neurological examination
• Corticotherapy prescribed
• General status of patient (world health organization score)
• Weight and height
• Control of arterial pressure
• Chirurgical and medical history
• Concomitant treatment

Intervention Type: OTHER

Other Intervention Names

fluoro-misonidazole; Cerebral MRI; Avastin

Eligibility Criteria

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
• Pregnant or lactating woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Benouaich-Amiel, MD

Role: PRINCIPAL_INVESTIGATOR

U H Toulouse

Locations

UHToulouse

Toulouse, , France

Countries

France

Other Identifiers

12 050 03

Identifier Type: -

Identifier Source: org_study_id