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

NCT02841332 | Terminated

• 1 other identifier: 12 050 03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

Recurrent Glioblastoma; Positron emission tomography; Fluoro misonidazole; MRI multimodal

Outcome Measures

Primary Outcomes (8)

• 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

  At day 15 after the 1st perfusion of bevacizumab

• 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

  At day 15 after the 1st perfusion of bevacizumab

• 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

  At day 15 after the 1st perfusion of bevacizumab

• 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

  At day 15 after the 1st perfusion of bevacizumab

• 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

  At day 60 after the 4th perfusion of bevacizumab

• 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

  At day 60 after the 4th perfusion of bevacizumab

• 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

  At day 60 after the 4th perfusion of bevacizumab

• 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

  At day 60 after the 4th perfusion of bevacizumab

Secondary Outcomes (30)

• 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 15 after the 1st perfusion of bevacizumab

• 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 15 after the 1st 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 15 after the 1st perfusion of bevacizumab

Study Arms (1)

Patients with glioblastoma

EXPERIMENTAL

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; Other: Cerebral magnetic resonance imagery; Drug: Bevacizumab; Other: Clinical examination

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.

Also known as: fluoro-misonidazole

Patients with glioblastoma

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

Also known as: Cerebral MRI

Patients with glioblastoma

Bevacizumab DRUG

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

Also known as: Avastin

Patients with glioblastoma

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

Patients with glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Pregnant or lactating woman

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Bevacizumab; Restraint, Physical

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Alexandra Benouaich-Amiel, MD

  U H Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: July 22, 2016
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)