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

NCT05569733 | Completed

• 1 other identifier: S58764-S58571
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Visual Snow Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Group difference in regional brain metabolism as assessed with 18F-FDG positron emission tomography

  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.

  Visual, voxel- and volume-of-interest based assessment of MRI images

  at baseline

Secondary Outcomes (4)

• Discriminant analysis of PET metabolic differences

  at baseline

• Visual scoring of PET metabolic differences

  at baseline

• Discriminant analysis of MR volumetric differences

  at baseline

• Visual scoring of MR volumetric differences

  at baseline

Study Arms (2)

VSS

Patients with visual snow syndrome

Diagnostic Test: simultaneous fluor-18 fluorodeoxyglucose (FDG) positron emission tomography with magnetic resonance imaging (PET/MRI)

controls

healthy, screened age-matched controls

Diagnostic Test: simultaneous fluor-18 fluorodeoxyglucose (FDG) positron emission tomography with magnetic resonance imaging (PET/MRI)

Interventions

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

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).

VSS; controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 : Visual Snow Syndrome patients Group 2 : Healthy Controls

You may qualify if:

• 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

You may not qualify if:

• \- other underlying neurological conditions inclusive ophthalmological examinations
• GROUP 2 : Controls
• 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.
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• Van Laere K, Ceccarini J, Gebruers J, Goffin K, Boon E. Simultaneous 18F-FDG PET/MR metabolic and structural changes in visual snow syndrome and diagnostic use. EJNMMI Res. 2022 Dec 30;12(1):77. doi: 10.1186/s13550-022-00949-0.

  PMID: 36583806 DERIVED

MeSH Terms

Conditions

visual snow syndrome

Interventions

Positron-Emission Tomography; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Koen Van Laere, MD PhD

  Head Nuclear Medicine, University Hospitals Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 6, 2022
• Study Start: January 2, 2017
• Primary Completion: September 2, 2017
• Study Completion: February 1, 2022
• Last Updated: January 27, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: Contact PI by email.