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)

October 15, 2021 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients with recurrent glioblastoma for whom the initiation of treatment with Bevacizumab is decided by the Neuro-oncology mulitdisciplinary committee at the Nîmes University Hospital.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laurent Collombier, CHU Nimes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Glioblastoma

Clinical Trials on FDG PET

3
Subscribe