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Trial record 26 of 158 for:    "Primary Central Nervous System Lymphoma"

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

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ClinicalTrials.gov Identifier: NCT03582254
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Primary Central Nervous System Lymphoma Radiation: [18F]-FDG PET/MR Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years
Actual Study Start Date : June 13, 2016
Estimated Primary Completion Date : May 12, 2020
Estimated Study Completion Date : May 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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).




Primary Outcome Measures :
  1. Progression free survival calculated from the date of completion of the end of chemotherapy PET [ Time Frame: 6 months ]
    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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582254


Contacts
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Contact: Aurélie KAS, Dr 01 42 17 62 81 aurelie.kas@aphp.fr
Contact: Marie-Odile HABERT, Dr 01 42 17 62 81 habert@imed.jussieu.fr

Locations
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France
Pitié Salpêtrière Hospital Recruiting
Paris, France, 75013
Contact: Aurélie KAS, Dr         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03582254     History of Changes
Other Study ID Numbers: AOR14101
2014-002597-37 ( EudraCT Number )
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases