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

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ClinicalTrials.gov Identifier: NCT02841332
Recruitment Status : Terminated (lack of recruitment)
First Posted : July 22, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: F-MISO Other: Cerebral magnetic resonance imagery Drug: Bevacizumab Other: Clinical examination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma
Study Start Date : May 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: 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
Drug: 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.

Other Name: fluoro-misonidazole

Other: 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
Other Name: Cerebral MRI

Drug: Bevacizumab
Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)
Other Name: Avastin

Other: 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




Primary Outcome Measures :
  1. Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron [ Time Frame: At day 15 after the 1st perfusion of bevacizumab ]

    Specific imagery parameters used are :

    Standard Uptake Value max, mean Standard Uptake Value, global or tumoral volume reported


  2. Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery [ Time Frame: At day 15 after the 1st perfusion of bevacizumab ]

    Specific imagery parameters used are :

    Cerebral blood volume and relative cerebral blood volume, absolute neo angiogenesis and reported to tumoral volume


  3. Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery [ Time Frame: At day 15 after the 1st 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


  4. Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery [ Time Frame: At day 15 after the 1st 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


  5. Detection capacity of patient clinical status in imagery with F-MISO as assessed by tomography with emission of positron [ Time Frame: 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


  6. Detection capacity of patient clinical status in imagery with F-MISO as assessed by Perfusion magnetic resonance imagery [ Time Frame: 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


  7. Detection capacity of patient clinical status in imagery with F-MISO as assessed by Diffusion magnetic resonance imagery [ Time Frame: 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


  8. Detection capacity of patient clinical status in imagery with F-MISO as assessed by Spectroscopy magnetic resonance imagery [ Time Frame: 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



Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. 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 ]
  21. 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 ]
  22. 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 ]
  23. 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 ]
  24. 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 ]
  25. 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 ]
  26. 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 ]
  27. 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 ]
  28. 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 ]
  29. 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 ]
  30. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841332


Locations
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France
UHToulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Alexandra Benouaich-Amiel, MD U H Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02841332    
Other Study ID Numbers: 12 050 03
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
Recurrent Glioblastoma
Positron emission tomography
Fluoro misonidazole
MRI multimodal
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Misonidazole
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents