Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03188354|
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : February 11, 2019
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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 Name: 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 Name: amino-acid PET-tracer
Diagnostic Test: standard MRI
clinical routine MRI examination, both for primary staging and response to therapy assessment.
Other Name: Magnetic resonance imaging
- sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans [ Time Frame: 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 [ Time Frame: 2 days ]of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination
- prediction of progression-free survival [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188354
|Contact: Live Eikenes, phd||++47 firstname.lastname@example.org|
|Contact: Trine Husby, email@example.com|
|Norwegian University of Science and Technology, Department of Circulation and Medical Imaging||Recruiting|
|Contact: Live Eikenes, phd firstname.lastname@example.org|
|Study Director:||Øystein Risa, phd||Norwegian University of Science and Technology, Department of Circulation and Medical Imaging|