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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03582254
Collaborator
(none)
62
Enrollment
1
Location
1
Arm
82.9
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: [18F]-FDG PET/MR
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
N/A
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 :
Jun 13, 2016
Actual Primary Completion Date :
May 12, 2021
Anticipated Study Completion Date :
May 12, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Progression free survival calculated from the date of completion of the end of chemotherapy PET [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).

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pitié Salpêtrière Hospital Paris France 75013

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03582254
Other Study ID Numbers:
  • AOR14101
  • 2014-002597-37
First Posted:
Jul 10, 2018
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Sep 10, 2021