Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia (HYPER-III)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03135574|
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : March 15, 2019
Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology.
It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment.
In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.
|Condition or disease||Intervention/treatment|
|Ophthalmoplegia||Diagnostic Test: MRI T2 sequence of the oculomotor tract|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia|
|Actual Study Start Date :||April 16, 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
- Diagnostic Test: MRI T2 sequence of the oculomotor tract
Patients with ophthalmoplegia will benefit from an MRI T2 sequence of the oculomotor tract (additional time of 4 minutes).
- High-intensity signal of the oculomotor nerve on MRI T2 sequence (presence or absence, determined by a radiologist) [ Time Frame: Baseline ]
High-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).
High-intensity signal on T2 MRI sequence is defined as a signal area which is more intense than the contralateral nerve or more intense than the white matter signal.
A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135574
|Contact: Laurence Salomon, MD PhD||148036431 ext firstname.lastname@example.org|
|Contact: Françoise Héran-Dreyfus, MD||148037406 ext email@example.com|
|Fondation Ophtalmologique A. de Rothschild||Recruiting|
|Paris, France, 75019|
|Contact: Françoise Héran-Dreyfus|