Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

• Status: Not yet recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

Summary

We 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France

Criteria

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