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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Central Nervous System Lymphoma
• Intervention / Treatment: Radiation: [18F]-FDG PET/MR

Detailed Description

[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).

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpétrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]-FDG PET/MR; [18F]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital	Radiation: [18F]-FDG PET/MR; [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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2016
• Primary Completion (Actual): May 12, 2021
• Study Completion (Anticipated): May 12, 2023

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: AOR14101; 2014-002597-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No