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

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 on the Use of Radiomics in Gliomas of Initial Disgnosis

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

How is the study designed?

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.	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	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.	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	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	Comparison of diagnostic performance of radiomics, static and dynamic parameters.	1 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Zaragori T, Oster J, Roch V, Hossu G, Chawki MB, Grignon R, Pouget C, Gauchotte G, Rech F, Blonski M, Taillandier L, Imbert L, Verger A. 18F-FDOPA PET for the Noninvasive Prediction of Glioma Molecular Parameters: A Radiomics Study. J Nucl Med. 2022 Jan;63(1):147-157. doi: 10.2967/jnumed.120.261545. Epub 2021 May 20.

Study record dates

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): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Glioma; Radiomics; 18F-FDOPA
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• 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