Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms
Conditions
Keywords
Positron-Emission Tomography, Magnetic Resonance Imaging
Brief 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.
Interventions
DIAGNOSTIC_TEST18F-FDG
PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
DIAGNOSTIC_TEST18F-fluciclovine
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
DIAGNOSTIC_TESTstandard MRI
clinical routine MRI examination, both for primary staging and response to therapy assessment.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans | 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 | 2 days | of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prediction of progression-free survival | 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 |
Countries
Norway
Outcome results
None listed