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出境医 / 临床实验 / 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) and Grading Glioma (GLIOFET)
18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) and Grading Glioma (GLIOFET)
Study Description
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)
| Condition or disease |
|---|
| Positron Emission Tomography Glioma |
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 Design
| Study Type : | Observational |
| Actual Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Role of 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) for Grading Glioma |
| Actual Study Start Date : | June 17, 2019 |
| Actual Primary Completion Date : | September 17, 2019 |
| Actual Study Completion Date : | September 17, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- quantitative criteria (SUVmax) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of SUVmax obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (TBRmax) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of TBRmax obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (SUVmean) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of SUVmean obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (TBRmean) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of TBRmean obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (SUVpeak) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of SUVpeak obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (métabolic tumoral volume MTV) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of MTV obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (Total Lesion Glycolysis TLG) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of TLG obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- quantitative criteria (SUVmin) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study mean value of SUVmin obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
Secondary Outcome Measures :
- qualitative criteria (Time Activity Curve TAC) between 2 groups (glioma II vs glioma III-IV) [ Time Frame: 3 months ]study qualitative data obtained by 18F-FET PET between 2 groups (glioma II vs glioma III-IV)
- agreement between readers for quantitative and qualitative criteria [ Time Frame: 3 months ]study inter and intra observers agreement
- diagnostic accuracy of clinical data to discriminate the 2 groups of glioma (symptom or size of tumor) [ Time Frame: 3 months ]study diagnostic accuracy of clinical data
- diagnostic accuracy of biological criteria (as MGMT mutation or IDH status or 1p19q codeletion, ATRX status) to discriminate the 2 groups of glioma [ Time Frame: 3 months ]study diagnostic accuracy of biological data
- diagnostic accuracy of PET criteria (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, TLG and MTV) between the 2 groups of glioma [ Time Frame: 3 months ]study diagnostic accuracy of PET data
- prognostic value of F-FET PET data on PET Baseline on PFS [ Time Frame: 2 years and 3 months ]study the prognostic value of PET criteria on PFS
- prognostic value of F-FET PET data on PET Baseline on OS [ Time Frame: 2 years and 3 months ]study the prognostic value of PET criteria on OS
- 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 [ Time Frame: 2 years and 3 months ]modification of PET criteria between PET Baseline and PET at follow-up and their prognostic value on PFS
- 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 [ Time Frame: 2 years and 3 months ]modification of PET criteria between PET Baseline and PET at follow-up and their prognostic value on OS
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
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
Contacts and Locations
Locations
| France | |
| CHRU de Brest | |
| Brest, France, 29609 | |
Sponsors and Collaborators
University Hospital, Brest
Investigators
| Study Chair: | solene querellou, MD | CHRU Brest |
| Tracking Information | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||||||||
| First Posted Date | June 28, 2019 | ||||||||||
| Last Update Posted Date | January 18, 2020 | ||||||||||
| Actual Study Start Date | June 17, 2019 | ||||||||||
| Actual Primary Completion Date | September 17, 2019 (Final data collection date for primary outcome measure) | ||||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||||
| Change History | |||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Descriptive Information | |||||||||||
| Brief Title | 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 | ||||||||||
| 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. | ||||||||||
| Study Type | Observational | ||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||
| Biospecimen | Not Provided | ||||||||||
| 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 | ||||||||||
| Condition |
|
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| Intervention | Not Provided | ||||||||||
| Study Groups/Cohorts | Not Provided | ||||||||||
| Publications * | Not Provided | ||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||
| Recruitment Status | Completed | ||||||||||
| Actual Enrollment |
60 | ||||||||||
| Original Estimated Enrollment | Same as current | ||||||||||
| Actual Study Completion Date | September 17, 2019 | ||||||||||
| Actual Primary Completion Date | September 17, 2019 (Final data collection date for primary outcome measure) | ||||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||||
| Accepts Healthy Volunteers | No | ||||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||
| Listed Location Countries | France | ||||||||||
| Removed Location Countries | |||||||||||
| Administrative Information | |||||||||||
| NCT Number | NCT04001257 | ||||||||||
| Other Study ID Numbers | GLIOFET (29BRC19.0140) | ||||||||||
| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Brest | ||||||||||
| Study Sponsor | University Hospital, Brest | ||||||||||
| Collaborators | Not Provided | ||||||||||
| Investigators |
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| PRS Account | University Hospital, Brest | ||||||||||
| Verification Date | January 2020 | ||||||||||
