Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
18F-FDG
18F-fluciclovine
standard MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma, Non-Hodgkin focused on measuring Positron-Emission Tomography, Magnetic Resonance Imaging
Eligibility Criteria
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
Sites / Locations
- Norwegian University of Science and Technology, Department of Circulation and Medical ImagingRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CNS lymphoma patients
Arm Description
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
Outcomes
Primary Outcome Measures
sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans
of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination
sensitivity and specificity of 18F-FDG-PET/MRI scans
of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination
Secondary Outcome Measures
prediction of progression-free survival
which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months
Full Information
NCT ID
NCT03188354
First Posted
June 13, 2017
Last Updated
December 16, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03188354
Brief Title
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
Official Title
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms
Keywords
Positron-Emission Tomography, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CNS lymphoma patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
Fluorine-18 Fluorodeoxyglucose
Intervention Description
PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-fluciclovine
Other Intervention Name(s)
amino-acid PET-tracer
Intervention Description
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
Intervention Type
Diagnostic Test
Intervention Name(s)
standard MRI
Other Intervention Name(s)
Magnetic resonance imaging
Intervention Description
clinical routine MRI examination, both for primary staging and response to therapy assessment.
Primary Outcome Measure Information:
Title
sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans
Description
of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination
Time Frame
2 days
Title
sensitivity and specificity of 18F-FDG-PET/MRI scans
Description
of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination
Time Frame
2 days
Secondary Outcome Measure Information:
Title
prediction of progression-free survival
Description
which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Live Eikenes, phd
Phone
++47 73551534
Email
live.eikenes@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Trine Husby, md
Email
trine.husby@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Risa, phd
Organizational Affiliation
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Live Eikenes, phd
Email
live.eikenes@ntnu.no
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
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