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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT05724641
Collaborator
(none)
70
1
3
41.6
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI perfusion imaging using ASL's non-invasive technique
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
Actual Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Experimental: 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.

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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Repeatability measurement on volunteers [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 Outcome Measures

  1. Mesurement of the retinal perfusion by MRI ASL in patient in acute phase [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 [4 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques Universitaires Saint Luc Brussels Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Idil Günes-Tatar, MD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT05724641
Other Study ID Numbers:
  • CUSL-2022-PerfRet
  • 2022/06DEC/471
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023