- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566185
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 (EVA DOPA)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Laurent Collombier
- Phone Number: 04.66.68.32.49
- Email: laurent.collombier@chu-nimes.fr
Study Locations
-
-
-
Nîmes, France, 30029
- Recruiting
- CHU de Nîmes
-
Principal Investigator:
- Laurent Collombier
-
Sub-Investigator:
- Benjamin Chambert
-
Sub-Investigator:
- Melanie Sainmont
-
Sub-Investigator:
- Vincent Boudousq
-
Sub-Investigator:
- Pierre-Olivier Kotzki
-
Sub-Investigator:
- Jean-Sébastien Guillamo
-
Sub-Investigator:
- Eric Thouvenot
-
Sub-Investigator:
- Anne Le Floch
-
Sub-Investigator:
- Anne-Sophie Pruvot-Occean
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with recurrent glioblastoma
|
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. 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. 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Tumor Volume
Time Frame: Day 0
|
FDG PET
|
Day 0
|
Metabolic Tumor Volume
Time Frame: Day 14
|
FDG PET
|
Day 14
|
Fixation Index
Time Frame: Day 0
|
Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata
|
Day 0
|
Fixation Index
Time Frame: Day 14
|
Maximum standard uptake value (SUV) and average SUV of the lesion divided by maximum SUV and average SUV of the striata
|
Day 14
|
permeability-surface area product
Time Frame: Day 0
|
CT scan
|
Day 0
|
permeability-surface area product
Time Frame: Day 14
|
CT scan
|
Day 14
|
cerebral blood flow
Time Frame: Day 0
|
CT scan
|
Day 0
|
cerebral blood flow
Time Frame: Day 14
|
CT scan
|
Day 14
|
Normalized permeability-surface area product to healthy brain
Time Frame: Day 0
|
CT scan
|
Day 0
|
Normalized permeability-surface area product to healthy brain
Time Frame: Day 14
|
CT scan
|
Day 14
|
Normalized cerebral blood flow to healthy brain
Time Frame: Day 0
|
CT scan
|
Day 0
|
Normalized cerebral blood flow to healthy brain
Time Frame: Day 14
|
CT scan
|
Day 14
|
Inter-rater reproducibility of FDG PET
Time Frame: End of study (September 2022)
|
LIN intraclass correlation coefficient
|
End of study (September 2022)
|
Inter-rater reproducibility of CT scan
Time Frame: End of study (September 2022)
|
LIN intraclass correlation coefficient
|
End of study (September 2022)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laurent Collombier, CHU Nimes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2018-03/LC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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