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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02841332
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Toulouse
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alexandra Benouaich-Amiel, MD
Principal Investigator Affiliation U H Toulouse
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Terminated
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

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

Interventions

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: - 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

Drug: - Bevacizumab

Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UHToulouse, Toulouse, France

Status

Address

UHToulouse

Toulouse, , 31000