Back to resultsMultimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma (IMAGLIO)
Primary Purpose
Glioblastoma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
F-MISO
Cerebral magnetic resonance imagery
Bevacizumab
Clinical examination
Sponsored by
About this trial
This is an interventional basic science trial for Glioblastoma focused on measuring Recurrent Glioblastoma, Positron emission tomography, Fluoro misonidazole, MRI multimodal
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
Sites / Locations
- UHToulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with glioblastoma
Arm 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
Outcomes
Primary Outcome Measures
Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron
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
Specific imagery parameters used are :
Cerebral blood volume and relative 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
Specific imagery parameters used are :
Apparent diffusion Coefficient and Apparent diffusion relative Coefficient , absolute elevated cellular density volume and reported to tumoral volume
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery
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
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
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
Specific imagery parameters used are :
Apparent diffusion Coefficient and Apparent diffusion relative Coefficient , absolute elevated cellular density volume and reported to tumoral volume
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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,
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT02841332
First Posted
November 3, 2014
Last Updated
December 18, 2016
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02841332
Brief Title
Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma
Acronym
IMAGLIO
Official Title
Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Recurrent Glioblastoma, Positron emission tomography, Fluoro misonidazole, MRI multimodal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with glioblastoma
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
F-MISO
Other Intervention Name(s)
fluoro-misonidazole
Intervention Description
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
Other
Intervention Name(s)
Cerebral magnetic resonance imagery
Other Intervention Name(s)
Cerebral MRI
Intervention Description
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
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)
Intervention Type
Other
Intervention Name(s)
Clinical examination
Intervention Description
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
Primary Outcome Measure Information:
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron
Description
Specific imagery parameters used are :
Standard Uptake Value max, mean Standard Uptake Value, global or tumoral volume reported
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery
Description
Specific imagery parameters used are :
Cerebral blood volume and relative cerebral blood volume, absolute neo angiogenesis and reported to tumoral volume
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery
Description
Specific imagery parameters used are :
Apparent diffusion Coefficient and Apparent diffusion relative Coefficient , absolute elevated cellular density volume and reported to tumoral volume
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery
Description
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
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron
Description
Specific imagery parameters used are :
Standard Uptake Value max, mean Standard Uptake Value, global or tumoral volume reported
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery
Description
Specific imagery parameters used are :
Cerebral blood volume and crelative cerebral blood volume, absolute neo angiogenesis and reported to tumoral volume
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery
Description
Specific imagery parameters used are :
Apparent diffusion Coefficient and Apparent diffusion relative Coefficient , absolute elevated cellular density volume and reported to tumoral volume
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery
Description
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
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Secondary Outcome Measure Information:
Title
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
Time Frame
at day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
at day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
at day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
at day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
at day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
at day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
at day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
at day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
at day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
at day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
At day 15 after the first perfusion of bevacizumab
Title
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
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
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,
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
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,
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
At day 15 after the 1st perfusion of bevacizumab
Title
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
Time Frame
At day 60 after the 4th perfusion of bevacizumab
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
Title
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
Time Frame
At day 15 and day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Benouaich-Amiel, MD
Organizational Affiliation
U H Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHToulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma
We'll reach out to this number within 24 hrs