Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years

Study Overview
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Brief Summary
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Patients older than 60 years account for half of cases of Primary Central Nervous System Lymphoma (PCNSL) and have a poorer outcome. No prognostic or predictive factors exist for survival after initial remission. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - Positron Emission Tomography ([18F]FDG-PET) plays a key role in grading and therapy monitoring of systemic diffuse large B-cell type. LOCALYZE is an ancillary Positron Emission Tomography / Magnetic Resonance (PET/MR) clinical study from BLOCAGE 01 (Pr Hoang-Xuan). The aim is to evaluate the usefulness of [18F]FDG-PET to monitor treatment response in PCNSL older than 60 years (n=56), in complement to multiparametric Magnetic Resonance Imaging (MRI). Hypothesis The investigators assume that the development of new imaging biomarker extracted from PET imaging and multiparametric MRI, could improve the assessment of treatment response in PCNSL.

Detailed Description
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[18F]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital: prior to initiation of chemotherapy (rituximab, methotrexate, procarbazine, vincristine and cytarabine) (PET#1), after two chemotherapy cycles (PET#2), at the end of the first-line chemotherapy regimens (PET#3).

Official Title
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Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Radiation: [18F]-FDG PET/MR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed primary cerebral lymphoma Age ≥60 years Pathology proven diagnosis or positive cytology of the Cerebrospinal Fluid (CSF) or vitreous Karnofsky Performance Status ≥40 No evidence of systemic Non-Hodgkin lymphomas (NHL) (body CT scan, bone marrow biopsy) Adequate haematological, renal and hepatic function Calculated creatinine clearance > 40 ml/min Exclusion Criteria: Uncontrolled diabetes with fasting glycaemia > 200 mg/dL Sensitivity to active substance in [18F]-FDG Calculated creatinine clearance < 40 ml/min No contraindication to MRI (magnetic resonance imaging)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]-FDG PET/MR<br>[18F]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital | Radiation: [18F]-FDG PET/MR<br>* [18F]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital: prior to initiation of chemotherapy (rituximab, methotrexate, procarbazine, vincristine and cytarabine) (PET#1), after two chemotherapy cycles (PET#2), at the end of the first-line chemotherapy regimens (PET#3).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival calculated from the date of completion of the end of chemotherapy PET | To evaluate the predictive value of [18F]FDG-PET assessment performed at the end-of-treatment (high-dose methotrexate based polychemotherapy), on progression free survival in newly diagnosed PCNSL with age ≥60 years (n=56). | 6 months |