Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
2 other identifiers
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 5, 2024
January 1, 2024
6.2 years
June 13, 2017
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
prediction of progression-free survival
1 year
Study Arms (1)
CNS lymphoma patients
EXPERIMENTALPatients 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
Interventions
PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
clinical routine MRI examination, both for primary staging and response to therapy assessment.
Eligibility Criteria
You may qualify if:
- Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy
- Written informed consent from patient or guardian
- Immunocompetent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
Trondheim, Norway
Related Publications (1)
Husby T, Johannessen K, Berntsen EM, Johansen H, Giskeodegard GF, Karlberg A, Fagerli UM, Eikenes L. 18F-FACBC and 18F-FDG PET/MRI in the evaluation of 3 patients with primary central nervous system lymphoma: a pilot study. EJNMMI Rep. 2024 Jan 31;8(1):2. doi: 10.1186/s41824-024-00189-6.
PMID: 38748286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Øystein Risa, phd
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 15, 2017
Study Start
November 1, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 5, 2024
Record last verified: 2024-01