18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) and Grading Glioma

Study Purpose

Role of 18F-FET PET for grading gliomas according to 2016 WHO classification: value of quantitative and qualitative data obtained by 18F-FET PET for differentiating low grade glioma (WHO II) versus high grade gliomas (WHO III and IV)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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:

- glial tumor - patient underwent 18F-FET PET at Brest University Hospital - no opposite to participate

Exclusion Criteria:

- patient Under 18 years old - opposite to participate

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.	NCT04001257
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.	University Hospital, Brest
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	solene querellou, MD
Principal Investigator Affiliation	CHRU Brest
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Positron Emission Tomography, Glioma

Additional Details

The management and prognosis of patients with glioma is highly dependent on the tumour grade according to the new 2016 classification of the World Health Organization (WHO), which incorporates molecular characteristics. Standard magnetic resonance imaging (MRI) enhanced by contrast is the basis of imaging primary brain tumours including gliomas. Nevertheless MRI specificity to type glioma is limited. Recently, positron emission tomography (PET) molecular imaging using radiolabeled amino acids or their analogues has been recommended by the Neuro-Oncology Response Assessment (RANO) working group for differential diagnosis of brain lesions, non-invasive classification of glial tumours, prognostic value, tumour delineation, stereotactic biopsy radiotherapy planification and treatments follow-up, to provide additional informations beyond MRI on biological processes such as cell proliferation, membrane biosynthesis, glucose consumption and absorption of amino acid analogues. Among the radiotracers used in PET, radiolabeled amino acids or their analogues are increasingly used in clinical routine for glioma imaging. Although most previous PET studies focused on brain gliomas used L-[methyl- 11 C] -methionine (11C-MET), the fluorinated amino acid analogue O

- (2-[ 18 F] fluoroethyl) -L-tyrosine (18F-FET) appeared to be a favorable marker for clinical routine due to his longer half-life than Carbone 11.

Recent european guidelines attempt to provide some guidance on the performance and interpretation of molecular imaging. The authors recommend a static (20-40 mn after injection (Pi)) or dynamic PET acquisition (40-50 mn from injection). A visual analysis can be completed by a quantitative analysis which consists to measure mean and maximal tumour activity uptake values (SUVmean and SUVmax) and their respective tumour to background ratios (TBRmean and TBRmax). Although the mean physiological brain activity uptake is well defined, the measurement of mean glioma activity uptake is less clear. Indeed, TBRmean depends on the delineation of the tumour ROI and/or VOI. Most often previously, VOI was determined by a 3D contouring process using a tumour-to-brain ratio of at least 1.6 at the beginning of the scan, threshold defined on a brain gliomas biopsy-controlled study. Moreover, Albert et al. emphasized the interest of early TBRmax.To our knowledge, none study evaluated others parameters as SUVmax, SUVmean and TBRmean in early period. In this context, the aim of this study was to compare quantitative and qualitative PET parameters between Low Grade Glioma and High Grade Glioma.

Contact a Trial Team

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International Sites

CHRU de Brest, Brest, France

Status

Recruiting

Address

CHRU de Brest

Brest, , 29609

Site Contact

Solene QUERELLOU

solene.querellou@chu-brest.fr

+33298223327

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