Clinical trial NCT04469244: Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas
Official title: Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Study on the Use of Radiomics in Gliomas of Initial Disgnosis
Keywords: 18F-FDOPA
Glioma
Radiomics
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: common population that underwent a PET/CT scan at 18F-FDOPA for its glioma

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.


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.

Primary outcomes:
measure: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence
timeFrame: 1 year
measure: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.
timeFrame: 1 year
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 1 years
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU of Nancy
Study officials:
References: