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

Role of 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) for Grading Glioma

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)

Study Overview

• Status: Completed
• Conditions: Glioma; Positron Emission Tomography

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantitative criteria (SUVmax) between 2 groups (glioma II vs glioma III-IV)	study mean value of SUVmax obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (TBRmax) between 2 groups (glioma II vs glioma III-IV)	study mean value of TBRmax obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (SUVmean) between 2 groups (glioma II vs glioma III-IV)	study mean value of SUVmean obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (TBRmean) between 2 groups (glioma II vs glioma III-IV)	study mean value of TBRmean obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (SUVpeak) between 2 groups (glioma II vs glioma III-IV)	study mean value of SUVpeak obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (métabolic tumoral volume MTV) between 2 groups (glioma II vs glioma III-IV)	study mean value of MTV obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (Total Lesion Glycolysis TLG) between 2 groups (glioma II vs glioma III-IV)	study mean value of TLG obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
quantitative criteria (SUVmin) between 2 groups (glioma II vs glioma III-IV)	study mean value of SUVmin obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
qualitative criteria (Time Activity Curve TAC) between 2 groups (glioma II vs glioma III-IV)	study qualitative data obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)	3 months
agreement between readers for quantitative and qualitative criteria	study inter and intra observers agreement	3 months
diagnostic accuracy of clinical data to discriminate the 2 groups of glioma (symptom or size of tumor)	study diagnostic accuracy of clinical data	3 months
diagnostic accuracy of biological criteria (as MGMT mutation or IDH status or 1p19q codeletion, ATRX status) to discriminate the 2 groups of glioma	study diagnostic accuracy of biological data	3 months
diagnostic accuracy of PET criteria (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, TLG and MTV) between the 2 groups of glioma	study diagnostic accuracy of PET data	3 months
prognostic value of F-FET PET data on PET Baseline on PFS	study the prognostic value of PET criteria on PFS	2 years and 3 months
prognostic value of F-FET PET data on PET Baseline on OS	study the prognostic value of PET criteria on OS	2 years and 3 months
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	modification of PET criteria between PET Baseline and PET at follow-up and their prognostic value on PFS	2 years and 3 months
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	modification of PET criteria between PET Baseline and PET at follow-up and their prognostic value on OS	2 years and 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Study Chair: solene querellou, MD, CHRU Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2019
• Primary Completion (ACTUAL): September 17, 2019
• Study Completion (ACTUAL): September 17, 2019

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (ACTUAL): June 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: glioma; grading; 18F-FET PET
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: GLIOFET (29BRC19.0140)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning Two and ending fivethree years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No