GlioblastomaEVA DOPANCT04566185
Evaluation of the Predictive Value of 18F-fluorodeoxyglucose Positron Emission Tomography and Brain Perfusion Computed Tomography for the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Recurrent Glioblastoma
A study testing FDG PET, CT scan and Magnetic resonance imaging (MRI) in people with Glioblastoma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- FDG PET, CT scan and Magnetic resonance imaging (MRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2020to 27 Jun 2023
- 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
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient has an WHO score ≤ 3
- The patient's estimated life expectancy is more than 3 months.
- Patient with histologically proven diagnosis of glioblastoma.
- Patient presenting with tumor progression on morphological MRI confirmed by a multidisciplinary committee.
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- Patient with a unilateral supratentorial target lesion upon inclusion to establish a tumor region of interest (ROI) zone and an equivalent ROI zone in contralateral healthy tissue.
- Patient progressing after radiotherapy and at least one line of chemotherapy with TEMODAL
- Patient in whom treatment with Bevacizumab monotherapy has been validated by a multidisciplinary committee.
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant or breast feeding patients
- Hypersensitivity to iodinated contrast media and creatinine clearance less than 60 ml / minute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Value of 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET) and Brain Perfusion Computed Tomography (CT Perfusion) for Predicting the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Patients With Recurrent Glioblastoma
In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.
- Conditions
- Glioblastoma
- Being tested
- FDG PET, CT scan, Magnetic resonance imaging (MRI)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PETOther
IV application of F Dopa, 2 MBq per Kg, with a scout view (angle of view 90 °, 120 kV, 30 mAs), then an X-ray scan is performed for the attenuation correction ( 120 kV - 5mAs - pitch 0.531 - thickness // increment: 3.75mm//3.27mm -QAC filter - DFOV 25).
PET acquisition: static in 3D mode for 20 minutes, 8 minutes after the injection of 18 F Dopa, the axial field of view is 25, the matrix in 256 x 256. After OSEM reconstruction 6 iterations and 24 subsets, with correction of attenuation and diffusion, then Gaussian filter of frequency 4, 47 contiguous axial sections of 3.26 mm are obtained.
CT scanOther
Localization propeller without injection: 120kV - mA regulation (Noise Index 15) - pitch 0.969 - thickness // increment: 5mm // 5mm - Soft filter - Asir 60% - DFOV 25.
Acquisition begins 5 seconds after the start of the injection of 60 ml of contrast product (VISIPAQUE) at 4 cc / second without (acquisition characteristics: 80 kV - 100 mAs -- thickness: 5mm // 8 images / rotation - STD filter - Asir 50% display field of view (DFOV) 25 - phase1: 5s then phase2 15s).
Diagnostic quality CT: 120kV - Regulation of mA (Noise Index 15) - pitch 0.531 - thickness // increment: 1.25 // 0.625mm - Soft filter - Asir 60% - DFOV 25.
Magnetic resonance imaging (MRI)Other
If the examination is performed on the SIEMENS SKYRA 3T device: 32 channel head coil antenna, if on the PHILIPPS INGENIA 1.5 T device: DStream HeadSpine Coil antenna.
The sequence begins with an axial, coronal and sagittal "Survey" topogram, lasting 1 minute.
Then axial sequence T1, Axial T2 *, Axial cerebral perfusion (Injection of gadolinium (0.1 mmol / kg, 5 cc / second), coronal T2, Axial T2 Flair, Axial DWI b100, Axial 3D T1 gadolinium
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent glioblastoma | Experimental | Not described Receives: Other: FDG PET; Other: CT scan; Other: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorization of patients as responders or non-responders to treatment
Measured by MRI according to Response Assessment in Neuro-Oncology (RANO) criteria: Complete response/Partial response/stable/progression
Measured: 2 months
Secondary outcomes (14)
Metabolic Tumor Volume
FDG PET
Measured: Day 0
Metabolic Tumor Volume
FDG PET
Measured: Day 14
Fixation Index
Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata
Measured: Day 0
Fixation Index
Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata
Measured: Day 14
permeability-surface area product
CT scan
Measured: Day 0
permeability-surface area product
CT scan
Measured: Day 14
cerebral blood flow
CT scan
Measured: Day 0
cerebral blood flow
CT scan
Measured: Day 14
Normalized permeability-surface area product to healthy brain
CT scan
Measured: Day 0
Normalized permeability-surface area product to healthy brain
CT scan
Measured: Day 14
Normalized cerebral blood flow to healthy brain
CT scan
Measured: Day 0
Normalized cerebral blood flow to healthy brain
CT scan
Measured: Day 14
Inter-rater reproducibility of FDG PET
LIN intraclass correlation coefficient
Measured: End of study (September 2022)
Inter-rater reproducibility of CT scan
LIN intraclass correlation coefficient
Measured: End of study (September 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start16 Dec 2020
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
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 Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Collombier, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566185
- Sponsor's protocol ID
- NIMAO/2018-03/LC-01
- Acronym
- EVA DOPA
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Value of 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET) and Brain Perfusion Computed Tomography (CT Perfusion) for Predicting the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04566185
- Acronym / sponsor ID
- EVA DOPA / NIMAO/2018-03/LC-01
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 28 Sep 2020 (actual)
- 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.
In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent glioblastoma | Experimental | Other: FDG PET, Other: CT scan, Other: Magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient has an WHO score ≤ 3
- The patient's estimated life expectancy is more than 3 months.
- Patient with histologically proven diagnosis of glioblastoma.
Key exclusion criteria (6 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant or breast feeding patients
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 |
|---|---|---|
| FDG PETIV application of F Dopa, 2 MBq per Kg, with a scout view (angle of view 90 °, 120 kV, 30 mAs), then an X-ray scan is performed for the attenuation correction ( 120 kV - 5mAs - pitch 0.531 - thickness // increment: 3.75mm//3.27mm -QAC filter - DFOV 25). PET acquisition: static in 3D mode for 20 minutes, 8 minutes after the injection of 18 F Dopa, the axial field of view is 25, the matrix in 256 x 256. After OSEM reconstruction 6 iterations and 24 subsets, with correction of attenuation and diffusion, then Gaussian filter of frequency 4, 47 contiguous axial sections of 3.26 mm are obtained. | Other | Patients with recurrent glioblastoma |
| CT scanLocalization propeller without injection: 120kV - mA regulation (Noise Index 15) - pitch 0.969 - thickness // increment: 5mm // 5mm - Soft filter - Asir 60% - DFOV 25. Acquisition begins 5 seconds after the start of the injection of 60 ml of contrast product (VISIPAQUE) at 4 cc / second without (acquisition characteristics: 80 kV - 100 mAs -- thickness: 5mm // 8 images / rotation - STD filter - Asir 50% display field of view (DFOV) 25 - phase1: 5s then phase2 15s). Diagnostic quality CT: 120kV - Regulation of mA (Noise Index 15) - pitch 0.531 - thickness // increment: 1.25 // 0.625mm - Soft filter - Asir 60% - DFOV 25. | Other | Patients with recurrent glioblastoma |
| Magnetic resonance imaging (MRI)If the examination is performed on the SIEMENS SKYRA 3T device: 32 channel head coil antenna, if on the PHILIPPS INGENIA 1.5 T device: DStream HeadSpine Coil antenna. The sequence begins with an axial, coronal and sagittal "Survey" topogram, lasting 1 minute. Then axial sequence T1, Axial T2 *, Axial cerebral perfusion (Injection of gadolinium (0.1 mmol / kg, 5 cc / second), coronal T2, Axial T2 Flair, Axial DWI b100, Axial 3D T1 gadolinium | Other | Patients with recurrent glioblastoma |
Primary outcome
Categorization of patients as responders or non-responders to treatment
Time frame: 2 months
Measured by MRI according to Response Assessment in Neuro-Oncology (RANO) criteria: Complete response/Partial response/stable/progression
14 secondary outcomes
Metabolic Tumor Volume
Time frame: Day 0
Metabolic Tumor Volume
Time frame: Day 14
Fixation Index
Time frame: Day 0
Fixation Index
Time frame: Day 14
permeability-surface area product
Time frame: Day 0
permeability-surface area product
Time frame: Day 14
cerebral blood flow
Time frame: Day 0
cerebral blood flow
Time frame: Day 14
Normalized permeability-surface area product to healthy brain
Time frame: Day 0
Normalized permeability-surface area product to healthy brain
Time frame: Day 14
Normalized cerebral blood flow to healthy brain
Time frame: Day 0
Normalized cerebral blood flow to healthy brain
Time frame: Day 14
Inter-rater reproducibility of FDG PET
Time frame: End of study (September 2022)
Inter-rater reproducibility of CT scan
Time frame: End of study (September 2022)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
Laurent Collombier principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET, CT scan and Magnetic resonance imaging (MRI) in people with Glioblastoma, run by Centre Hospitalier Universitaire de Nīmes 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 18 Dec 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Categorization of patients as responders or non-responders to treatment (time frame: 2 months). 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 18 Dec 2025.