Clinical trial · Interventional
Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-FDG PET/MR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]-FDG PET/MR
- description
- \[18F\]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital
- interventionNames
- Radiation: [18F]-FDG PET/MR
Primary outcomes (1)
- measure
- Progression free survival calculated from the date of completion of the end of chemotherapy PET
- timeFrame
- 6 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDRozenblum L, Houillier C, Baptiste A, Soussain C, Edeline V, Naggara P, Soret M, Causse-Lemercier V, Willems L, Choquet S, Ursu R, Galanaud D, Belin L, Hoang-Xuan K, Kas A. Interim FDG-PET improves treatment failure prediction in primary central nervous system lymphoma: An LOC network prospective multicentric study. Neuro Oncol. 2024 Jul 5;26(7):1292-1301. doi: 10.1093/neuonc/noae029. PMID 38366824