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

Not Applicable

Completed

• Conditions: Lymphoma, Non-Hodgkin; Central Nervous System Neoplasms
• Interventions: Diagnostic Test: 18F-FDG; Diagnostic Test: 18F-fluciclovine; Diagnostic Test: standard MRI

• Registration Number: NCT03188354
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Study Start: 2017-11-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CNS lymphoma patients	18F-fluciclovine	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
CNS lymphoma patients	18F-FDG	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
CNS lymphoma patients	standard MRI	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Norwegian University of Science and Technology, Department of Circulation and Medical Imaging; 🇳🇴 Trondheim, Norway