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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    10
  • sponsor
    Norwegian University of Science and Technology
Updated on 22 December 2021
hodgkin's disease
flow cytometry
colony stimulating factor
histological diagnosis
primary cns lymphoma

Summary

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.

Details
Condition Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms
Treatment 18F-FDG, 18F-Fluciclovine, standard MRI
Clinical Study IdentifierNCT03188354
SponsorNorwegian University of Science and Technology
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

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
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