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

Retinal Diseases Clinical Trial

— PerfRet  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724641
• Other study ID #: CUSL-2022-PerfRet
• Secondary ID: 2022/06DEC/471
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Idil Günes-Tatar, MD
• Phone: +32.276442544
• Email: idil.gunes[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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