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

NCT03582254 | Unknown

• 2 other identifiers: AOR141012014-002597-37
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

[18F]-FDG PET/MR

EXPERIMENTAL

\[18F\]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital

Radiation: [18F]-FDG PET/MR

Interventions

[18F]-FDG PET/MR RADIATION

\[18F\]-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).

[18F]-FDG PET/MR

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

Related Publications (1)

• Rozenblum 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 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: June 13, 2016
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2023
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)