- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188354
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Live Eikenes, phd
- Phone Number: ++47 73551534
- Email: live.eikenes@ntnu.no
Study Contact Backup
- Name: Trine Husby, md
- Email: trine.husby@ntnu.no
Study Locations
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Trondheim, Norway
- Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
Other Names:
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
Other Names:
clinical routine MRI examination, both for primary staging and response to therapy assessment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans
Time Frame: 2 days
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of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination
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2 days
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sensitivity and specificity of 18F-FDG-PET/MRI scans
Time Frame: 2 days
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of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination
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2 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prediction of progression-free survival
Time Frame: 1 year
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which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Øystein Risa, phd, Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Lymphoma
- Lymphoma, Non-Hodgkin
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- PET/MRI_CNS_LYMPHOMA
- 2017-000306-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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