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

Primary Purpose

Retinal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MRI perfusion imaging using ASL's non-invasive technique
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retinal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy Volunteers

Chronic

Acute

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
December 15, 2022
Last Updated
February 1, 2023
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05724641
Brief Title
Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
Acronym
PerfRet
Official Title
Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
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.
Arm Title
Chronic
Arm Type
Experimental
Arm Description
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.
Arm Title
Acute
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI perfusion imaging using ASL's non-invasive technique
Intervention Description
Patients will undergo through an MRI-scan using the ASL MRI sequence, as described per protocol.
Primary Outcome Measure Information:
Title
Repeatability measurement on volunteers
Description
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 Outcome Measure Information:
Title
Mesurement of the retinal perfusion by MRI ASL in patient in acute phase
Description
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
Title
Mesurement of the retinal perfusion by MRI ASLin patient in a chronic phase
Description
Following up the disease process (stability, progression or reversal of the decrease in visual acuity).
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idil Günes-Tatar, MD
Phone
+32.276442544
Email
idil.gunes@saintluc.uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Duprez, MD
Phone
+32.276442919
Email
thierry.duprez@saintluc.uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idil Günes-Tatar, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine Triqueneaux
Phone
003227642935
Email
perrine.triqueneaux@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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