Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics as Biomarkers for the Improvement of Care of MRI Non-contrast Enhanced Gliomas

Trial ID: NCT05512403

Interventional - Phase 3 - Recruiting

the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis

Conditions

• Glioma

Interventions

• PET/CT with 18F-DOPA

Eligibility

Inclusion criteria

• Age between 18 and 75 years old
• WHO general condition ≤2
• Identification of a unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan
• MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
• Subject affiliated to or beneficiary of a social security plan
• Subject having received complete information on the organisation of the research and having signed the informed consent form.

Exclusion criteria

• Multifocal brain lesions
• Contraindication to 18F-FDOPA PET
• Pregnant, parturient women or nursing mothers under Article L1121-5
• Women of childbearing age who do not have effective contraception under Article L1121-5
• Monitoring not possible
• Persons deprived of their liberty by a judicial or administrative decision under Article 1121-8, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
• Patients cannot simultaneously participate in an interventional research trial for the duration of the KING study

Sponsor

Central Hospital, Nancy, France

Source: ClinicalTrials.gov

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