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

Primary Central Nervous System Lymphoma Clinical Trial

— LOCALYSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03582254
• Other study ID #: AOR14101
• Secondary ID: 2014-002597-37
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: May 12, 2023

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

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).

Locations

Country	Name	City	State
France	Pitié Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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