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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT03188354

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Central Nervous System Neoplasms	Diagnostic Test: 18F-FDG Diagnostic Test: 18F-fluciclovine Diagnostic Test: standard MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: 18F-FDG PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment. Other Names: Fluorine-18 Fluorodeoxyglucose Diagnostic Test: 18F-fluciclovine PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment. Other Names: amino-acid PET-tracer Diagnostic Test: standard MRI clinical routine MRI examination, both for primary staging and response to therapy assessment. Other Names: Magnetic resonance imaging

Arm

Intervention/Treatment

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

Diagnostic Test: 18F-FDG

PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.

Other Names:

Fluorine-18 Fluorodeoxyglucose

Diagnostic Test: 18F-fluciclovine

PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.

Other Names:

amino-acid PET-tracer

Diagnostic Test: standard MRI

clinical routine MRI examination, both for primary staging and response to therapy assessment.

Other Names:

Magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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