Evaluation of the Use of a Method "Radiomics" for DOPA PET in Gliomas

NCT06472440 | Completed

• 1 other identifier: 2024PI089
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

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

  Accuracy of the method

  Day 1

Secondary Outcomes (2)

• Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence

  Day 1

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

  Day 1

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for a brain PET/CT examination using 18F-FDOPA (between 01/JAN/2020 and 01/JUN/2024) and presenting a histologically confirmed glioma

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU of NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of University and Medical Doctor, MD PhD

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 25, 2024
• Study Start: November 16, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (1)