NCT04001257

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

June 21, 2019

Last Update Submit

January 14, 2020

Conditions

Positron Emission TomographyGlioma

Keywords

18F-FET PETgliomagrading

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (9)

  • qualitative criteria (Time Activity Curve TAC) between 2 groups (glioma II vs glioma III-IV)

    3 months

  • agreement between readers for quantitative and qualitative criteria

    3 months

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

    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

    3 months

  • diagnostic accuracy of PET criteria (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, TLG and MTV) between the 2 groups of glioma

    3 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • patient Under 18 years old
  • opposite to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • solene querellou, MD

    CHRU Brest

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 28, 2019

Study Start

June 17, 2019

Primary Completion

September 17, 2019

Study Completion

September 17, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning Two and ending fivethree years following the publication
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.

Locations

FR(1)