Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas (RADDOPAG)

August 23, 2022 updated by: Antoine VERGER, Central Hospital, Nancy, France
The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54511
        • CHRU of Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

common population that underwent a PET/CT scan at 18F-FDOPA for its glioma

Description

Inclusion Criteria:

  • Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the nuclear medicine department of the CHRU de Brabois for which the raw data are available;
  • Person who received full information on the organization of the research and did not object to the use of these data;
  • Patients affiliated to a social security scheme

Exclusion Criteria:

  • - Person who received full information on the organization of the research and who objected to the use of the data
  • Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
  • A person of full age who is unable to give consent and who is not subject to a legal protection measure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.
Time Frame: 1 year
Evaluating the performance of radiomics use in gliomas at initial diagnosis
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence
Time Frame: 1 year
Assessing the performance of radiomics use in the search for glioma recurrence
1 year
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.
Time Frame: 1 year
Evaluating the performance of the use of radiomics in the follow-up of glioma disease treatments
1 year
Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
Time Frame: 6 months
Optimization of dynamic analysis for the interpretation of the PET/CT examination at 18F-FDOPA
6 months
Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
Time Frame: 1 years
Comparison of diagnostic performance of radiomics, static and dynamic parameters.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI063

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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