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NCT Number: NCT05724641

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

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.

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Key information

Conditions

Retinal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location status: Recruiting

Location contact

Perrine Triqueneaux

CONTACT

[email protected]

003227642935

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Repeatability measurement on volunteers

    Time frame: 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 outcomes

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

    Time frame: 4 years

    Analysing the retinal perfusion by ASL to be able to figure out if the decreased visual acuity has an ischemic etiology.

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

    Time frame: 4 years

    Following up the disease process (stability, progression or reversal of the decrease in visual acuity).

Study contacts

Contact information is provided by the study sponsor or research team.

Idil Günes-Tatar, MD

CONTACT

[email protected]

+32.276442544

Thierry Duprez, MD

CONTACT

[email protected]

+32.276442919

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: PerfRet

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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