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Clinical Trials/NCT06472440
NCT06472440
Completed
Not Applicable

Evaluation of the Use of a Method "Radiomics" for Positons Emission Tomography With Fluor-18-Fluoro-DOPA PET in Gliomas

Central Hospital, Nancy, France1 site in 1 country1,000 target enrollmentNovember 16, 2024
ConditionsGlioma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioma
Sponsor
Central Hospital, Nancy, France
Enrollment
1000
Locations
1
Primary Endpoint
Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

: 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

Registry
clinicaltrials.gov
Start Date
November 16, 2024
End Date
February 1, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Antoine VERGER

Professor of University and Medical Doctor, MD PhD

Central Hospital, Nancy, France

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.

Time Frame: Day 1

Accuracy of the method

Secondary Outcomes

  • Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.(Day 1)
  • Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence(Day 1)

Study Sites (1)

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