[18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study
- Conditions
- Patients with newly diagnosed primary central nervous system lymphoma naïve to surgery, radiotherapy or chemotherapy
- Registration Number
- 2024-512758-62-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.
- Detailed Description
Monocenter, open, uncontrolled and non-randomized pilot study designed to evaluate the uptake of \[18F\]-Fludarabine in 16 patients with newly diagnosed CNS lymphoma at initial diagnosis, before treatment using hybrid PET/MR system.
Main objective: to characterize the brain distribution and tumoral uptake in CNS lymphoma before treatment. The secondary objectives are to compare PET-\[18F\]-Fludarabine results with those of morphological MRI with and without gadolinium injection, diffusion and perfusion MRI, proton-spectroscopy, histological or cytological diagnosis, and brain \[18F\]-FDG PET imaging.
Patient screening includes a clinical and neurological examination, diagnostic MRI, biological examination, \[18F\]-FDG PET examination to exclude systemic lymphoma, histological/cytological diagnosis of brain lymphoma. Once informed consent is obtained, one brain PET with \[18F\]-Fludarabine (4 MBq/kg) combined with simultaneous multiparametric MR sequences is scheduled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 10
Patients aged ≥ 18 years
Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation)
Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma
Contrast-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 the informed consent by the patient or by a legal representative or the close relative if the patient is not able to do so
Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
History of allergy to gadolinium chelates (DOTAREM®)
Absolute contraindication to MRI (pacemaker, cochlear implant ...), to the administration of gadolinium
Patient of childbearing potential without effective contraception, breastfeeding or pregnant
Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination
Patient with pain or restlessness unable to remain motionless in supine position for 60 minutes
Weight > 100 Kg
Patient deprived of liberty or under legal protection (guardianship or curatorship)
Ongoing participation in another interventional research protocol. Participation in research of a non-interventional type is authorized
Traitement antérieur pour un lymphome primitif du système nerveux central
Isolated primary vitro-retinal lymphoma
Isolated CNS relapse of a systemic lymphoma
Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ
Immunosuppression (organ transplant in particular)
Treatment with dipyridamole
Positive HIV serology
Presence of another progressive pathology that is life-threatening in the short term
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI. Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.
- Secondary Outcome Measures
Name Time Method Tumor/healthy tissue contrast on PET-[18F]-Fludarabine Tumor/healthy tissue contrast on PET-[18F]-Fludarabine
Cerebral distribution and activity-time curves for [18F]-Fludarabine Cerebral distribution and activity-time curves for [18F]-Fludarabine
Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG
lesion volumes in 3D T1 MRI with Gadolinium lesion volumes in 3D T1 MRI with Gadolinium
Apparent diffusion coefficient (ADC) in diffusion MRI Apparent diffusion coefficient (ADC) in diffusion MRI
Tumor perfusion in perfusion MRI Tumor perfusion in perfusion MRI
Metabolite ratios in spectroscopy Metabolite ratios in spectroscopy
histological or cytological diagnosis histological or cytological diagnosis
Trial Locations
- Locations (1)
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
Hôpital Pitié Salpêtrière🇫🇷Paris, France