Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application

Not Applicable

Recruiting

• Conditions: Retinal Diseases
• Interventions: Diagnostic Test: MRI perfusion imaging using ASL's non-invasive technique

• Registration Number: NCT05724641
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The MRI perfusion imaging using arterial spin labeling (ASL)'s non-invasive technique (i.e. without injection of contrast medium) allows, thanks to recent technological improvement of the spatial resolution, measuring several perfusion parameter of the retinal tissue such as the regional Blood Flow (rBF) or the cerebral blood flow (cBF) expressed in ml/100g/min. Reliable application of ASL thus requires the precision and specificity of the MRI protocol to be tested.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-15
• Study Start: 2023-01-10
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic	MRI perfusion imaging using ASL's non-invasive technique	N = 30 (10 patients with thyroid associated orbitopathy (TAO), 10 patients with inflammatory optic neuropathy (ION), 10 patients with ischemic neuropathy), all chronic patients followed in ophthalmology consultation, enlightened volunteers ta participate in the study, and presenting a decrease in residual visual acuity entering the TAO, inflammatory or ischemic frameworks.
Healthy Volunteers	MRI perfusion imaging using ASL's non-invasive technique	N = 10, who do not use contact lenses or eye glasses and have a recent evaluation of vision 10/10 ta participate in the repeatability study.
Acute	MRI perfusion imaging using ASL's non-invasive technique	N = 30 (10 patients with TAO, 10 patients with ION, 10 patients with ischemic neuropathy) all patients seen in the acute phase in ophthalmology consultation who will accept participation in the study, knowing the constraint of repeating the examination in the chronic phase.

Primary Outcome Measures

Name	Time	Method
Repeatability measurement on volunteers	2 month	implementing a protocol based on 2 imaging sessions : 1st session with 2 ASL sequences and a 2nd session scheduled 5-7 days later in similar conditions including 1 ASL in volunteers will be applied. This protocol allows assessing the intra-day and the inter-day variability of the measurements using Intra-Class Correlation Coefficient and metric derived from Bland-Altman plots. A total of 20 MRI examinations are planned for this phase of the study.

Secondary Outcome Measures

Name	Time	Method
Mesurement of the retinal perfusion by MRI ASL in patient in acute phase	4 years	Analysing the retinal perfusion by ASL to be able to figure out if the decreased visual acuity has an ischemic etiology.
Mesurement of the retinal perfusion by MRI ASLin patient in a chronic phase	4 years	Following up the disease process (stability, progression or reversal of the decrease in visual acuity).

Trial Locations

Locations (1)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium