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

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.

Study Overview

• Status: Recruiting
• Conditions: Retinal Diseases
• Intervention / Treatment: Diagnostic test: MRI perfusion imaging using ASL's non-invasive technique

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Idil Günes-Tatar, MD; Phone Number: +32.276442544; Email: idil.gunes@saintluc.uclouvain.be
• Study Contact Backup: Name: Thierry Duprez, MD; Phone Number: +32.276442919; Email: thierry.duprez@saintluc.uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint Luc
    • Contact: Perrine Triqueneaux; Phone Number: 003227642935; Email: perrine.triqueneaux@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Carrier of target pathologies: TAO optic neuropathy, inflammatory optic neuropathy, ischemic optic neuropathy.
• no cardiovascular risk factors or other ophthalmological pathology
• adhere to the study protocol after reading the patient information document
• signe the informed consent form to participate in the study
• do not have any contraindications to an MRI examination

Exclusion criteria

• Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
• Severe claustrophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; 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.	Diagnostic test: MRI perfusion imaging using ASL's non-invasive technique; Patients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol.
Experimental: Chronic; 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.	Diagnostic test: MRI perfusion imaging using ASL's non-invasive technique; Patients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol.
Experimental: Acute; 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.	Diagnostic test: MRI perfusion imaging using ASL's non-invasive technique; Patients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability measurement on volunteers	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.	2 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Idil Günes-Tatar, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: CUSL-2022-PerfRet; 2022/06DEC/471 (Other Identifier: CEHF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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