cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04566185
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Hospitalier Universitaire de Nīmes
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Laurent Collombier
Principal Investigator Affiliation CHU Nimes
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

: Patients with recurrent glioblastoma

Interventions

Other: - FDG PET

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.

Other: - CT scan

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.

Other: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Nimes, Nîmes, France

Status

Recruiting

Address

CHU de Nimes

Nîmes, , 30029

Site Contact

Anissa Megzari

[email protected]

04.66.68.42.36

Powered By