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

Sponsor
University Hospital, Toulouse
Study ID
NCT02841332
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • F-MISO — 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 — 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 — DRUG
    Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)
  • Clinical examination — 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

Study Details

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.

Key Dates

First listed
Jul 22, 2016
Start date
May 31, 2013
Status verified
Dec 2016
Primary completion
Sep 30, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

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 ]

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