Retinal DiseasesPerfRetNCT05724641
Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
A study testing MRI perfusion imaging using ASL's non-invasive technique in people with Retinal Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Diseases
- What is being tested?
- MRI perfusion imaging using ASL's non-invasive technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
Perrine Triqueneaux, 003227642935, perrine.triqueneaux@uclouvain.be
About this study
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.
- Conditions
- Retinal Diseases
- Being tested
- MRI perfusion imaging using ASL's non-invasive technique
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI perfusion imaging using ASL's non-invasive techniqueDiagnostic test
Patients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | 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. Receives: Diagnostic Test: MRI perfusion imaging using ASL's non-invasive technique |
| Chronic | Experimental | 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. Receives: Diagnostic Test: MRI perfusion imaging using ASL's non-invasive technique |
| Acute | Experimental | 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. Receives: Diagnostic Test: MRI perfusion imaging using ASL's non-invasive technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month
Secondary outcomes (2)
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.
Measured: 4 years
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).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start10 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Idil Günes-Tatar, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724641
- Sponsor's protocol ID
- CUSL-2022-PerfRet
- Other IDs
- 2022/06DEC/471
- Acronym
- PerfRet
- Status last verified
- May 2025
- First submitted
- 15 Dec 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
- ClinicalTrials.gov ID
- NCT05724641
- Acronym / sponsor ID
- PerfRet / CUSL-2022-PerfRet
- Conditions
- Retinal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Diagnostic Test: MRI perfusion imaging using ASL's non-invasive techniqueN = 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. |
| Chronic | Experimental | Diagnostic Test: MRI perfusion imaging using ASL's non-invasive techniqueN = 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. |
| Acute | Experimental | Diagnostic Test: MRI perfusion imaging using ASL's non-invasive techniqueN = 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
- Severe claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI perfusion imaging using ASL's non-invasive techniquePatients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol. | Diagnostic test | Acute, Chronic, Healthy Volunteers |
Primary outcome
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.
2 secondary outcomes
Mesurement of the retinal perfusion by MRI ASL in patient in acute phase
Time frame: 4 years
Mesurement of the retinal perfusion by MRI ASLin patient in a chronic phase
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Idil Günes-Tatar, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI perfusion imaging using ASL's non-invasive technique in people with Retinal Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Idil Günes-Tatar, MD (+32.276442544, idil.gunes@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability measurement on volunteers (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.