Clinical trial NCT02841332: Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma
Official title: Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glioblastoma
Keywords: Recurrent Glioblastoma
Positron emission tomography
Fluoro misonidazole
MRI multimodal
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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
* 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

Primary outcomes:
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
Secondary outcomes:
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with relative cerebral blood volume in Perfusion magnetic resonance imagery
timeFrame: at day 15 after the 1st perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with relative cerebral blood volume in Perfusion magnetic resonance imagery
timeFrame: at day 60 after the 4th perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with apparent diffusion coefficient on diffusion magnetic resonance imagery
timeFrame: at day 15 after the 1st perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with apparent diffusion coefficient on diffusion magnetic resonance imagery
timeFrame: at day 60 after the 4th perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with rate of choline on spectroscopy magnetic resonance imagery
timeFrame: at day 15 after the 1st perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with rate of choline on spectroscopy magnetic resonance imagery
timeFrame: at day 60 after the 4th perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with rate of N-acetyl aspartate on spectroscopy magnetic resonance imagery
timeFrame: at day 15 after the 1st perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with rate of N-acetyl aspartate on spectroscopy magnetic resonance imagery
timeFrame: at day 60 after the 4th perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with rate of rate of creatinine on spectroscopy magnetic resonance imagery
timeFrame: at day 15 after the 1st perfusion of bevacizumab
measure: Estimation of predictive parameters of progression free survival with a sensibility of change of at least 75% as assessed with rate of rate of creatinine on spectroscopy magnetic resonance imagery
timeFrame: at day 60 after the 4th perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by relative cerebral blood volume in Perfusion magnetic resonance imagery
timeFrame: At day 15 after the first perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by relative cerebral blood volume in Perfusion magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by apparent diffusion coefficient on diffusion magnetic resonance imagery,
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by apparent diffusion coefficient on diffusion magnetic resonance imagery,
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by rate of choline on spectroscopy magnetic resonance imagery
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by rate of choline on spectroscopy magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by N-acetyl aspartate on spectroscopy magnetic resonance imagery
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by N-acetyl aspartate on spectroscopy magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed byrate of creatinine on spectroscopy magnetic resonance imagery
timeFrame: At day 15 after the 1st perfusion of bevacizumab
measure: Estimation of imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% as assessed by rate of creatinine on spectroscopy magnetic resonance imagery
timeFrame: At day 60 after the 4th perfusion of bevacizumab
measure: Variation in imagery predictive parameters for progression free survival with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by relative cerebral blood volume in Perfusion magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery predictive parameters for progression free survival with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by apparent diffusion coefficient on diffusion magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery predictive parameters for progression free survival with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by rate of choline on spectroscopy magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery predictive parameters for progression free survival with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by N-acetyl aspartate on spectroscopy magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery predictive parameters for progression free survival with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by rate of creatinine on spectroscopy magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by relative cerebral blood volume in Perfusion magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by apparent diffusion coefficient on diffusion magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by rate of choline on spectroscopy magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by rate of N-acetyl aspartate on spectroscopy magnetic resonance imagery
timeFrame: At day 15 and day 60
measure: Variation in imagery prognostic parameters for global survival at 6 months with a sensibility of change of at least 75% between cycle 1 and cycle 4 of treatment as assessed by rate of creatinine on spectroscopy magnetic resonance imagery
timeFrame: At day 15 and day 60
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: U H Toulouse
name: Alexandra Benouaich-Amiel, MD
role: PRINCIPAL_INVESTIGATOR
References: