- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793087
Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis (COCON) (COCON)
March 11, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild
Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination
3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI.
Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D T1 sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS).
No study has yet investigated the detection capabilities of 3D T1 for the detection of optic nerve inflammation.
The objective of this retrospective study was to determine whether a single 3D T1 sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ile-de-France
-
Paris, Ile-de-France, France, 75019
- Hôpital Fondation Adolphe de Rothschild
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with visual acuity loss explored by MRI between january 2018 and january 2020
Description
Inclusion Criteria:
- Age > 18 years
- Decrease in visual acuity explored in MRI between january 2018 and january 2020
Exclusion Criteria:
- Past history of episode of Optic neuritis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of optic neuropathies using MRI
Time Frame: 1 hour
|
MRI comparison of the diagnostic performance of the 3D T1 sequence and the T1 coronal in the detection of optic neuropathies.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
August 30, 2020
Study Registration Dates
First Submitted
March 8, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 15, 2021
Last Update Submitted That Met QC Criteria
March 11, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Multiple Sclerosis
- Neuritis
- Optic Neuritis
Other Study ID Numbers
- CE_20200204_2_ALR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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