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Positron Emission TomographyGLIOFETNCT04001257

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

An observational study of Positron Emission Tomography and Glioma, run by University Hospital, Brest at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Positron Emission Tomography, Glioma
How many people
60 participants
Where
1 siteFrance
Study dates
17 Jun 2019to 17 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patient with glioma histologically proven (grades II, III and IV according to WHO 2016) underwent 18F-FET PET at Brest university hospital

Who may be able to join

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

Who cannot join

  • patient Under 18 years old
  • opposite to participate

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU de Brest

    Brest, 29609

Other trials in France

About this study

Official title: 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)

Read the 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.

Keywords
18F-FET PET, glioma, grading
Medical subject headings
Glioma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 3 months

  2. 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)

    Measured: 3 months

  3. 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)

    Measured: 3 months

  4. 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)

    Measured: 3 months

  5. 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)

    Measured: 3 months

  6. 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)

    Measured: 3 months

  7. 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)

    Measured: 3 months

  8. 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)

    Measured: 3 months

Secondary outcomes (9)

  1. 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)

    Measured: 3 months

  2. agreement between readers for quantitative and qualitative criteria

    study inter and intra observers agreement

    Measured: 3 months

  3. diagnostic accuracy of clinical data to discriminate the 2 groups of glioma (symptom or size of tumor)

    study diagnostic accuracy of clinical data

    Measured: 3 months

  4. 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

    Measured: 3 months

  5. 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

    Measured: 3 months

  6. prognostic value of F-FET PET data on PET Baseline on PFS

    study the prognostic value of PET criteria on PFS

    Measured: 2 years and 3 months

  7. prognostic value of F-FET PET data on PET Baseline on OS

    study the prognostic value of PET criteria on OS

    Measured: 2 years and 3 months

  8. 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

    Measured: 2 years and 3 months

  9. 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

    Measured: 2 years and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2019
  2. Study start17 Jun 2019
  3. Primary completion17 Sep 2019
  4. Study completion17 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04001257
Sponsor's protocol ID
GLIOFET (29BRC19.0140)
Acronym
GLIOFET
Status last verified
Jan 2020
First submitted
21 Jun 2019
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

An observational study of Positron Emission Tomography and Glioma, run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quantitative criteria (SUVmax) between 2 groups (glioma II vs glioma III-IV) (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04001257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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