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

NCT ID: NCT05724641

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Retinal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRI perfusion imaging using ASL's non-invasive technique

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

MRI perfusion imaging using ASL's non-invasive technique

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

MRI perfusion imaging using ASL's non-invasive technique

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Idil Günes-Tatar, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Idil Günes-Tatar, MD

Role: CONTACT

+32.276442544

Thierry Duprez, MD

Role: CONTACT

+32.276442919

Facility Contacts

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Perrine Triqueneaux

Role: primary

003227642935

Other Identifiers

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2022/06DEC/471

Identifier Type: OTHER

Identifier Source: secondary_id

CUSL-2022-PerfRet

Identifier Type: -

Identifier Source: org_study_id

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