Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma

Overview

Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or non-neoplastic diseases. Positron emission tomography (PET) could have a number of potential advantages in refining and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL, the value of PET has however not been well defined in this subtype of lymphomas. There are a few studies that have investigated the role for FDG-PET and amino acid PET in the primary staging/diagnosis and response assessment in PCNSL patients, but the results are inconclusive. Further studies are therefore needed. Previous studies support an integration of both MRI and PET for the routine diagnostic workup and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may have the potential to improve imaging baseline accuracy, response assessment and add prognostic value in PCNSL. The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI examination with the clinical routine MRI examination given to these patients today. It will be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic value at baseline and in response assessment compared to MRI and established pre-treatment prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an imaging biomarker for progression-free survival.

Full Title of Study: “Diagnostic Assessment of 18F-fluciclovine and 18F-FDG – PET/MRI of Primary Central Nervous System Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Interventions

  • Diagnostic Test: 18F-FDG
    • PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
  • Diagnostic Test: 18F-fluciclovine
    • PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
  • Diagnostic Test: standard MRI
    • clinical routine MRI examination, both for primary staging and response to therapy assessment.

Arms, Groups and Cohorts

  • Experimental: CNS lymphoma patients
    • Patients included in the study will be examined with both 18F-FDG and 18F-Fluciclovine as well as standard MRI in the PET/MRI scanner on two consecutive days, both in primary staging and for therapy assessment

Clinical Trial Outcome Measures

Primary Measures

  • sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans
    • Time Frame: 2 days
    • of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination
  • sensitivity and specificity of 18F-FDG-PET/MRI scans
    • Time Frame: 2 days
    • of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination

Secondary Measures

  • prediction of progression-free survival
    • Time Frame: 1 year
    • which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy – Written informed consent from patient or guardian – Immunocompetent Exclusion Criteria:

  • Previous chemotherapy – Contra-indications for MRI (Pacemakers, defibrillators, aneurysm clips, any form of metal in the body, or severe claustrophobia) – Hypersensitivity to either 18F-Fluciclovine or 18F-FDG or to any of the excipients – Pregnancy (pregnancy test for all women in fertile age) – Breastfeeding – Weight > 120 kg – Estimated glomerular filtration rate (eGFR) <30ml/min/1,73m2 – HIV-positive

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Norwegian University of Science and Technology
  • Collaborator
    • St. Olavs Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Øystein Risa, phd, Study Director, Norwegian University of Science and Technology, Department of Circulation and Medical Imaging

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.