glioma (grade OMS II à IV) MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]DPA-714
Product Code: sub267533
Pharmaceutical Form: Injection/infusion
INN or Proposed INN: [18F]DPA-714
Other descriptive name: N,N-diethyl-2-(2-(4-(2[(18)F]-fluoroethoxy)phenyl)5
Sponsors
Centre de Lutte Contre le Cancer Eugène Marquis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years 2. Suspicion of an operable diffuse glioma 3. Written informed consent (signed) 4. Affiliated or beneficiary of a social security plan Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Suspicion de gliome de grade I 2. Urgence chirurgicale (délai inférieur à 8 jours entre la suspicion diagnostique et la chirurgie) 3. Femme enceinte ou en cours d'allaitement 4. Personnes privées de liberté ou sous tutelle 5. Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: valuation of the diagnostic performance of [18F]DPA-714 PET in grading obtained by stereotactic biopsies of glioma;Secondary Objective: Comparison of quantitative [18F]DPA-714 PET parameters with histological type (astrocytoma or oligodendroglioma). Comparison of quantitative parameters of [18F]DPA-714 PET with the presence or absence of an Isocitrate dehydrogenase type 1 (IDH1) mutation and the presence or absence of a 1p19q co-deletion. Comparison of quantitative [18F]DPA-714 PET parameters and tumor microenvironment characteristics. Translated with www.DeepL.com/Translator (free version);Primary end point(s): The diagnostic performance of quantitative [18F]DPA-714 PET uptake parameters will be evaluated. The diagnostic ability of each parameter, i.e., the categorization of each stereotactic biopsy according to its histological grade assessed in pathology, of each PET parameter will be evaluated by the area under the ROC curve, as well as the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy rate for a given threshold maximizing the Youden index. There was no preferred diagnostic indicator chosen as the primary endpoint. The study is a pilot study and does not attempt to draw any definitive conclusions (inferences). Translated with www.DeepL.com/Translator (free version);Timepoint(s) of evaluation of this end point: At surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quantitative [18F]DPA-714 PET parameters will be compared according to histological type (astrocytoma or oligodendroglioma), presence or absence of IDH1 mutation, 1p19q co-deletion, and the characteristics of the tumor microenvironment (i.e. presence and quantity of immune (CD45 marker), microglial/macrophagic (CD14, CD49d, CD68, CD163, HLA-DR, IBA-1 markers), endothelial (CD31) infiltrating cells; as well as the presence of tumor cells, and the presence of transcriptomic markers characterizing the tumor sample ;Timepoint(s) of evaluation of this end point: At surgery | — |
Countries
France
Contacts
Public ContactClinical project manager
Centre de Lutte Contre le Cancer Eugène Marquis
Outcome results
None listed