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Simultaneous Fluorodeoxyglucose Positron Emission Tomography (PET) and Magnetic Resonance (MR) in Visual Snow Syndrome

Simultaneous Fluorodeoxyglucose and Magnetic Resonance Imaging (18F-FDG PET/MR) Study of Metabolic and Structural Changes in Visual Snow Syndrome Compared to Healthy Controls

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05569733
Enrollment
22
Registered
2022-10-06
Start date
2017-01-02
Completion date
2022-02-01
Last updated
2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Snow Syndrome

Keywords

FDG PET, PET/MR, volumetry, visual analysis, discriminant analysis

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTsimultaneous fluor-18 fluorodeoxyglucose (FDG) positron emission tomography with magnetic resonance imaging (PET/MRI)

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).

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Group difference in regional brain metabolism as assessed with 18F-FDG positron emission tomographyanalysis done immediately after imagingVisual, voxel- and volume-of-interest based assessment of of FDG PET
Group difference in regional brain volume assessed with volumetric magnetic resonance imaging.at baselineVisual, voxel- and volume-of-interest based assessment of MRI images

Secondary

MeasureTime frameDescription
Discriminant analysis of PET metabolic differencesat baselineStatistical discriminant analysis of FDG between VSS patients and controls
Visual scoring of PET metabolic differencesat baselineVisual scoring of FDG between VSS patients and controls
Discriminant analysis of MR volumetric differencesat baselineStatistical discriminant analysis of regional MR volumetry between VSS patients and controls
Visual scoring of MR volumetric differencesat baselineVisual scoring of regional MR volumetry between VSS patients and controls

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026