GlioblastomaIMAGLIONCT02841332
Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma
A study testing F-MISO, Cerebral magnetic resonance imagery and Bevacizumab in people with Glioblastoma, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- F-MISO, Cerebral magnetic resonance imagery and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- F-MISO, Cerebral magnetic resonance imagery, Bevacizumab, Clinical examination
- Keywords
- Recurrent Glioblastoma, Positron emission tomography, Fluoro misonidazole, MRI multimodal
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-MISODrug
Also called fluoro-misonidazole
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 imageryOther
Also called Cerebral MRI
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
BevacizumabDrug
Also called Avastin
Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)
Clinical examinationOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: F-MISO; Other: Cerebral magnetic resonance imagery; Drug: Bevacizumab; Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 rate of choline on spectroscopy magnetic resonance imagery
Measured: 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 N-acetyl aspartate on spectroscopy magnetic resonance imagery
Measured: 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 rate of N-acetyl aspartate on spectroscopy magnetic resonance imagery
Measured: 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 rate of creatinine on spectroscopy magnetic resonance imagery
Measured: 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 rate of rate of creatinine on spectroscopy magnetic resonance imagery
Measured: at day 60 after the 4th perfusion of bevacizumab
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
Measured: At day 15 after the first perfusion of bevacizumab
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
Measured: At day 60 after the 4th perfusion of bevacizumab
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,
Measured: At day 15 after the 1st perfusion of bevacizumab
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,
Measured: At day 60 after the 4th perfusion of bevacizumab
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
Measured: At day 15 after the 1st perfusion of bevacizumab
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
Measured: At day 60 after the 4th perfusion of bevacizumab
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
Measured: At day 15 after the 1st perfusion of bevacizumab
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
Measured: At day 60 after the 4th perfusion of bevacizumab
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
Measured: At day 15 after the 1st perfusion of bevacizumab
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
Measured: At day 60 after the 4th perfusion of bevacizumab
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
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
Measured: At day 15 and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionDec 2016
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Benouaich-Amiel, MD, Principal investigator, U H Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841332
- Sponsor's protocol ID
- 12 050 03
- Acronym
- IMAGLIO
- Status last verified
- Dec 2016
- First submitted
- 3 Nov 2014
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT02841332
- Acronym / sponsor ID
- IMAGLIO / 12 050 03
- Conditions
- Glioblastoma
- Keywords
- Recurrent Glioblastoma, Positron emission tomography, Fluoro misonidazole, MRI multimodal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with glioblastoma | Experimental | Drug: F-MISO, Other: Cerebral magnetic resonance imagery, Drug: Bevacizumab, Other: Clinical examinationPatient with histologically proved glioblastoma diagnostic will receive the following interventions : * Cerebral magnetic resonance imagery * Tomography emission positron with F-MISO * Bevacizumab administration * Clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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) .
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-MISOAlso: fluoro-misonidazoleThe 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. | Drug | Patients with glioblastoma |
| Cerebral magnetic resonance imageryAlso: Cerebral MRIDuring 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 | Patients with glioblastoma |
| BevacizumabAlso: AvastinAdministration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180) | Drug | Patients with glioblastoma |
| Clinical examinationDuring 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 | Other | Patients with glioblastoma |
Primary outcome
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
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
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
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
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
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
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
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
30 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No
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RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Benouaich-Amiel, MD principal investigator
U H Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-MISO, Cerebral magnetic resonance imagery and Bevacizumab in people with Glioblastoma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.