Patients with newly diagnosed primary lymphoma of the central nervous system who have not been treated with surgery, radiotherapy or chemotherapy.
Conditions
Interventions
Product Name: [18F]-Fludarabine
Product Code: [18F]-Fludarabine
Pharmaceutical Form: Concentrate for emulsion for infusion
Sponsors
ASSISTANCE PUBLIQUE-HÔPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged = 18 years • Diagnosis of newly diagnosed high grade CNS lymphoma (with histological and / or cytological confirmation) • Patient naïve to chemotherapy or radiotherapy treatment for CNS lymphoma • Constrat-enhanced intracranial mass greater than or equal to 1 cm longest axis • Karnofsky index = 40 • No systemic lymphoma on [18F]–FDG PET-CT • Creatinine clearance = 30 ml / min • Social security affiliation (excluding AME) • Signature of informed consent by the patient or by a legal representative or the close relative if the patient is not in a position to do so 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 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F] -Fludarabine or gadolinium • Previous treatment for primary CNS lymphoma • Isolated primary vitro-retinal lymphoma • Isolated CNS relapse of a systemic lymphoma • Other active cancer except basal cell carcinoma of the skin or / and cervical cancer in situ • Immunosuppression (organ transplant in particular) • Positive HIV serology • Presence of another progressive pathology that is life-threatening in the short term • Treatment with dipyridamole • History of allergy to gadolinium chelates (DOTAREM®) • Absolute contraindication to MRI (pacemaker, cochlear implant ect), to the administration of [18F] FDG or gadolinium • Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination • Patient with pain or restlessness unable to remain motionless in the supine position for 60 minutes • Weight> 100 Kg • Patient of childbearing potential without effective contraception or breastfeeding • Patient deprived of liberty or under legal protection (guardianship or curatorship) • Ongoing participation in another intervention research protocol. Participation in research of a non-interventional type is authorized. • Vulnerable population (pregnant or breastfeeding women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the cerebral distribution and [18F] -Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET/MR imaging;Secondary Objective: The secondary objectives relate to the comparison of [18F] -Fludarabine PET findings with those of: - 3D T1 MRI before and after injection of Gadolinium chelates; - parametric MRI (diffusion, perfusion, spectroscopy) acquired during the same session with a hybrid PET-MR system; - PET- [18F] -FDG (location of hypermetabolic foci, tumor/normal tissue contrast); - cytological or anatomopathological examination. ;Primary end point(s): Measurements of [18F] -Fludarabine uptake in tumoral lesions and normal tissue using SUV, tumor/normal tissues ratios, on PET images fused with MRI.;Timepoint(s) of evaluation of this end point: After the brain exam | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary evaluation criteria related to the stated objectives are: - Cerebral distribution of [18F] -Fludarabine in healthy and tumoral tissues - Temporal activity curves of [18F] -Fludarabine in healthy and tumoral tissues - Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F] -FDG - Volumes of contrast enhancement in post-gadolinium T1-weighted MR sequence - Hypersignal in diffusion-weighted sequence and apparent diffusion coefficient (ADC) - Tumor perfusion, capillary permeability in perfusion weighted MRI - metabolite ratios in spectroscopy ;Timepoint(s) of evaluation of this end point: After the brain exam | — |
Countries
France
Contacts
Public ContactPôle Promotion-DRCI
ASSISTANCE PUBLIQUE-HÔPITAUX DE PARIS (AP-HP)
Outcome results
None listed