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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDG PET

Other

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 scan

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Metabolic Tumor Volume

    Time frame: Day 0

    FDG PET

  2. Metabolic Tumor Volume

    Time frame: Day 14

    FDG PET

  3. 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

  4. 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

  5. permeability-surface area product

    Time frame: Day 0

    CT scan

  6. permeability-surface area product

    Time frame: Day 14

    CT scan

  7. cerebral blood flow

    Time frame: Day 0

    CT scan

  8. cerebral blood flow

    Time frame: Day 14

    CT scan

  9. Normalized permeability-surface area product to healthy brain

    Time frame: Day 0

    CT scan

  10. Normalized permeability-surface area product to healthy brain

    Time frame: Day 14

    CT scan

  11. Normalized cerebral blood flow to healthy brain

    Time frame: Day 0

    CT scan

  12. Normalized cerebral blood flow to healthy brain

    Time frame: Day 14

    CT scan

  13. Inter-rater reproducibility of FDG PET

    Time frame: End of study (September 2022)

    LIN intraclass correlation coefficient

  14. Inter-rater reproducibility of CT scan

    Time frame: End of study (September 2022)

    LIN intraclass correlation coefficient

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: EVA DOPA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2020
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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