Simultaneous Fluorodeoxyglucose Positron Emission Tomography (PET) and Magnetic Resonance (MR) in Visual Snow Syndrome
January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
Simultaneous Fluorodeoxyglucose and Magnetic Resonance Imaging (18F-FDG PET/MR) Study of Metabolic and Structural Changes in Visual Snow Syndrome Compared to Healthy Controls
Visual snow syndrome (VSS) is a neurologic condition where patients experience tiny flickering dots in their entire visual field.
It has been reported that the brain consumes more glucose in the lingual gyrus (a subdivision of the occipital cortex) and that this also shows increased volume of grey matter (neurons and supporting cells).
In this study, the investigators apply fluor-18 fluorodeoxyglucose positron emission tomography with magnetic resonance imaging (18F-FDG PET/MR) in patients with VSS and compare this to healthy controls.
Aside from an analysis in each brain volume element (voxel), the accuracy of classifying groups based on a volume-of-interest (VOI) analysis of both PET and MR is studied, Lastly, this is also compared to a visual assessment of the PET and MR images.
Study Overview
Status
Completed
Conditions
Detailed Description
Aim : Prospective measurement of brain glucose metabolism and structural integrity in the brain of subjects with visual snow syndrome (VSS). Voxel-based and volume-of interest comparison to age matched healthy controls retrospectively obtained on the same simultaneous PET/MR imaging system.
Hypothesis : 1/ VSS patients show overactivation of parts of the visual system, in particular the lingual gyrus, which is likely related to larger volume of the gyrus on structural imaging. 2/ Discrimination of VSS patients versus controls can be done by visual read of FDG PET and/or volume-of-interest based discriminant analysis.
Methods : Recruitment through neurology practice specialised in VSS, detailed history taking and assessment of in/exclusion criteria, scanning with simultaneous18F-FDG PET/MR Signa GE Healthcare.
Analysis : visual assessment, group-based voxel and volume-of-interest based analysis (FDG PET, volumetry T1 MRI) with appropriate statistics and corrections for multiple regional comparisons. Discriminant analysis on VOI based data. Dual observer scoring of visual data and assessment of accuracy, sensitivity and specificity of visual image analysis compared to clinical final diagnosis.
Study Type
Observational
Enrollment (Actual)
22
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Group 1 : Visual Snow Syndrome patients Group 2 : Healthy Controls
Description
GROUP 1: VSS Patients
Inclusion Criteria:
- M/F, age 18-85,
- diagnosis of VSS by an experienced neurologist : dynamic, continuous, black and white tiny dots in the entire visual field lasting longer than 3 months, with at least two additional visual symptoms
Exclusion Criteria:
- other underlying neurological conditions inclusive ophthalmological examinations
GROUP 2 : Controls
Inclusion Criteria:
- age 18-85 years, M/F, in general healthy condition
- normal neurological examination, Mini-Mental State Examination (MMSE) ≥ 28, Beck's Depression Inventory (BDI) score ≤ 9, and a normal structural volumetric MRI.
Exclusion Criteria:
- history of major internal pathology, neurological and/or psychiatric disorders (including psychosis, depression, and anxiety),
- history of frequent migraine attacks, substance abuse or current use of any central acting medication
- first-degree relatives with dementia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
VSS
Patients with visual snow syndrome
|
All subjects fast at least for 4 hours prior to 18F-FDG injection.
18F-FDG is injected intravenously (150 megabecquerel (MBq)) in standard ambient conditions, supine in a dark, noise free room with eyes and ears open.
18F-FDG PET images are acquired for 20 min on a simultaneous GE Signa 3 Tesla (3T) PET/MR scanner with integrated Time-of-Flight (TOF) (GE Healthcare, Chicago, USA).
Simultaneous with the 18F-FDG PET/MR acquisition, zero-echo-time (ZTE) MR data are acquired for attenuation correction and a 3D volumetric T1-weighted BRAVO MR sequence using a vendor supplied high-resolution 8-channel phased array head coil (GE Healthcare, Milwaukee, USA).
|
|
controls
healthy, screened age-matched controls
|
All subjects fast at least for 4 hours prior to 18F-FDG injection.
18F-FDG is injected intravenously (150 megabecquerel (MBq)) in standard ambient conditions, supine in a dark, noise free room with eyes and ears open.
18F-FDG PET images are acquired for 20 min on a simultaneous GE Signa 3 Tesla (3T) PET/MR scanner with integrated Time-of-Flight (TOF) (GE Healthcare, Chicago, USA).
Simultaneous with the 18F-FDG PET/MR acquisition, zero-echo-time (ZTE) MR data are acquired for attenuation correction and a 3D volumetric T1-weighted BRAVO MR sequence using a vendor supplied high-resolution 8-channel phased array head coil (GE Healthcare, Milwaukee, USA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group difference in regional brain metabolism as assessed with 18F-FDG positron emission tomography
Time Frame: analysis done immediately after imaging
|
Visual, voxel- and volume-of-interest based assessment of of FDG PET
|
analysis done immediately after imaging
|
|
Group difference in regional brain volume assessed with volumetric magnetic resonance imaging.
Time Frame: at baseline
|
Visual, voxel- and volume-of-interest based assessment of MRI images
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discriminant analysis of PET metabolic differences
Time Frame: at baseline
|
Statistical discriminant analysis of FDG between VSS patients and controls
|
at baseline
|
|
Visual scoring of PET metabolic differences
Time Frame: at baseline
|
Visual scoring of FDG between VSS patients and controls
|
at baseline
|
|
Discriminant analysis of MR volumetric differences
Time Frame: at baseline
|
Statistical discriminant analysis of regional MR volumetry between VSS patients and controls
|
at baseline
|
|
Visual scoring of MR volumetric differences
Time Frame: at baseline
|
Visual scoring of regional MR volumetry between VSS patients and controls
|
at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Koen Van Laere, MD PhD, Head Nuclear Medicine, University Hospitals Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2017
Primary Completion (Actual)
September 2, 2017
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
October 3, 2022
First Posted (Actual)
October 6, 2022
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S58764-S58571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Data can be shared on a reasonable request, including full FDG PET and MRI data as well as supporting information.
IPD Sharing Access Criteria
Contact PI by email.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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