Clinical trial NCT04001257: 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) and Grading Glioma
Official title: Role of 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) for Grading Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Positron Emission Tomography
Glioma
Keywords: 18F-FET PET
glioma
grading
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with glioma histologically proven (grades II, III and IV according to WHO 2016) underwent 18F-FET PET at Brest university hospital

Brief summary: 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)

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: quantitative criteria (SUVmax) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (TBRmax) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (SUVmean) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (TBRmean) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (SUVpeak) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (métabolic tumoral volume MTV) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (Total Lesion Glycolysis TLG) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: quantitative criteria (SUVmin) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
Secondary outcomes:
measure: qualitative criteria (Time Activity Curve TAC) between 2 groups (glioma II vs glioma III-IV)
timeFrame: 3 months
measure: agreement between readers for quantitative and qualitative criteria
timeFrame: 3 months
measure: diagnostic accuracy of clinical data to discriminate the 2 groups of glioma (symptom or size of tumor)
timeFrame: 3 months
measure: diagnostic accuracy of biological criteria (as MGMT mutation or IDH status or 1p19q codeletion, ATRX status) to discriminate the 2 groups of glioma
timeFrame: 3 months
measure: diagnostic accuracy of PET criteria (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, TLG and MTV) between the 2 groups of glioma
timeFrame: 3 months
measure: prognostic value of F-FET PET data on PET Baseline on PFS
timeFrame: 2 years and 3 months
measure: prognostic value of F-FET PET data on PET Baseline on OS
timeFrame: 2 years and 3 months
measure: prognostic value of variation of quantitative PET data (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, MTV, TLG) (for example deltaSUVmax between PET Baseline and PET 3 months) on PFS
timeFrame: 2 years and 3 months
measure: prognostic value of variation of quantitative PET data (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, MTV, TLG) (for example deltaSUVmax between PET Baseline and PET 3 months) on OS
timeFrame: 2 years and 3 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU Brest
name: solene querellou, MD
role: STUDY_CHAIR
References: