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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms

Intervention / Treatment
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* Diagnostic Test: 18F-FDG
* Diagnostic Test: 18F-fluciclovine
* Diagnostic Test: standard MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNS lymphoma patients<br>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 | Diagnostic Test: 18F-FDG<br>* PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.<br>* Other names: Fluorine-18 Fluorodeoxyglucose;Diagnostic Test: 18F-fluciclovine<br>* PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.<br>* Other names: amino-acid PET-tracer;Diagnostic Test: standard MRI<br>* clinical routine MRI examination, both for primary staging and response to therapy assessment.<br>* Other names: Magnetic resonance imaging;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron-Emission Tomography, Magnetic Resonance Imaging