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

NCT05724641 | Recruiting

• 2 other identifiers: CUSL-2022-PerfRet2022/06DEC/471
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mesurement of the retinal perfusion by MRI ASL in patient in acute phase

  4 years

• Mesurement of the retinal perfusion by MRI ASLin patient in a chronic phase

  4 years

Study Arms (3)

Healthy Volunteers

EXPERIMENTAL

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

Chronic

EXPERIMENTAL

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

Acute

EXPERIMENTAL

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

Interventions

MRI perfusion imaging using ASL's non-invasive technique DIAGNOSTIC_TEST

Patients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol.

Acute; Chronic; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Idil Günes-Tatar, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idil Günes-Tatar, MD

CONTACT

+32.276442544; idil.gunes@saintluc.uclouvain.be

Thierry Duprez, MD

CONTACT

+32.276442919; thierry.duprez@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 13, 2023
• Study Start: January 10, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)