KING (Phase IIIb)

Investigator physician: Pr Antoine VERGER

Evaluation of diagnostic performances of ¹⁸F-FDOPA PET KInetics as biomarkers for the improvement of care of MRI Non-contrast enhanced Gliomas

Suspicion of Glioma with MRI non contrast enhanced

This prospective, longitudinal, multicenter, interventional and open-label study will be carried out in 12 French neuro-oncology and nuclear medicine departments, and 88 patients will be included. The inclusion period will be 30 months, with a maximum follow-up of 6 months.
The study will recruit patients whose cases are discussed at a neuro-oncology multidisciplinary consultation meeting. Indeed, these patients presented clinical disorders leading them to consult. A cerebral MRI was prescribed, and the result showed a non-contrast lesion suggestive of a low-grade glioma. Following the RCP, neuro-oncologists or neurosurgeons will suggest that these patients take part in the KING study.

A request for an ¹⁸F-FDOPA PET/CT scan will then be sent to the relevant nuclear medicine department.

The patient will be included in the study by the nuclear physician in the nuclear medicine department, and an ¹⁸F-FDOPA PET/CT will be recorded in "list mode" for 30 minutes (Visit 1).

The decision to proceed with biopsy or surgery will be done according to local practice, clinical parameters and MRI results.
After 6 months, all ¹⁸F-FDOPA PET/CT scans and biopathology materials will be pseudonymized with an inclusion number and sent to the Nancy CHRU for centralized analysis.

Diagnostic: TEP/TDM au ¹⁸F-FDOPA
Study status: Recruiting
Clinical Trial number: NCT05512403
Funding: PHRC-K InCA