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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Severe claustrophobia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: Healthy VolunteersExperimental treatment 1 intervention
Group B: ChronicExperimental treatment 1 intervention
Group C: AcuteExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 month

Secondary outcomes

1

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.

Time frame
4 years
2

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).

Time frame
4 years

Other outcomes

Sponsors and contacts

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