Clinical trial

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

Name

2020PI126

Description

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

Trial arms

Trial start

2023-06-13

Estimated PCD

2025-12-12

Trial end

2026-10-30

Status

Recruiting

Phase

Early phase I

Treatment

PET/CT with 18F-DOPA

A 18F-FDOPA PET exam is then performed (acquisition of 30 minutes in List Mode format) according to the French guidelines for PET neuro-oncological indications (Verger et al. Med Nuc, 2020, (5)). Patient preparation and acquisition: * 4 hours of fasting * No carbidopa premedication * 2 MBq / kg of 18F-FDOPA * Dynamic acquisition in List Mode format for 30 min starting simultaneously with the patient's injection * Low dose scanner for attenuation correction

Arms:

Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement

Size

Primary endpoint

To assess diagnostic performances of 18F-FDOPA PET (Positon Emission Tomography) Time-To-Peak in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions

24 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}

Updated at

2023-07-06

1 organization

Organization

Central Hospital