Evaluation of diagnostic performances of 18F-FDOPA PET KInetics as biomarkers for the improvement of care of MRI Non-contrast enhanced Gliomas : a phase IIIb exploratory trial
- Conditions
- ow Grade GliomaMedDRA version: 20.0Level: PTClassification code: 10018338Term: Glioma Class: 100000004864Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-501688-42-00
- Lead Sponsor
- Centre Hospitalier Regional Universitaire De Nancy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
Age between 18 and 75 years old, WHO general condition =2, Identification of an 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/CT, 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.
Multifocal brain lesions, Contraindication to 18F-FDOPA PET, Concomitant treatment by Carbidopa, Halopéridol, Réserpine and MAOIs., 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method