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

Not Applicable

Terminated

• Conditions: Glioblastoma
• Interventions: Drug: F-MISO; Other: Cerebral magnetic resonance imagery; Drug: Bevacizumab; Other: Clinical examination

• Registration Number: NCT02841332
• Lead Sponsor: University Hospital, Toulouse

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Primary Completion: 2016-09
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-18
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with glioblastoma	F-MISO	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
Patients with glioblastoma	Cerebral magnetic resonance imagery	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
Patients with glioblastoma	Clinical examination	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
Patients with glioblastoma	Bevacizumab	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

Primary Outcome Measures

Name	Time	Method
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery	At day 60 after the 4th perfusion of bevacizumab	Specific imagery parameters used are : choline pike, NAA pike, mean and maximal creatinine pike, mean and maximal ratio choline/NAA, mean and maximal ratio choline/creatinine
Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron	At day 60 after the 4th perfusion of bevacizumab	Specific imagery parameters used are : Standard Uptake Value max, mean Standard Uptake Value, global or tumoral volume reported
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery	At day 60 after the 4th perfusion of bevacizumab	Specific imagery parameters used are : Cerebral blood volume and crelative cerebral blood volume, absolute neo angiogenesis and reported to tumoral volume
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery	At day 60 after the 4th perfusion of bevacizumab	Specific imagery parameters used are : Apparent diffusion Coefficient and Apparent diffusion relative Coefficient , absolute elevated cellular density volume and reported to tumoral volume

Secondary Outcome Measures

Name	Time	Method
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	at day 60 after the 4th perfusion of bevacizumab
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	at day 60 after the 4th perfusion of bevacizumab
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	at day 60 after the 4th perfusion of bevacizumab
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	at day 60 after the 4th perfusion of bevacizumab
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	at day 60 after the 4th perfusion of bevacizumab
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	At day 60 after the 4th perfusion of bevacizumab
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,	At day 60 after the 4th perfusion of bevacizumab
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	At day 60 after the 4th perfusion of bevacizumab
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	At day 60 after the 4th perfusion of bevacizumab
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	At day 15 after the 1st perfusion of bevacizumab
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	At day 60 after the 4th perfusion of bevacizumab
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60
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	At day 15 and day 60

Trial Locations

Locations (1)

UHToulouse; 🇫🇷 Toulouse, France