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

NCT ID: NCT04469244

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Study on the Use of Radiomics in Gliomas of Initial Disgnosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antoine VERGER

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU of Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020PI063

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HYPONCO - Hypoxia in Brain Tumors
NCT01200134 COMPLETED PHASE2