Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia

Ophthalmoplegia Clinical Trial

— 3D-III  

Official title:

Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269682
• Other study ID #: FHN_2017_4
• Status: Completed
• Start date: October 20, 2017
• Est. completion date: April 16, 2021

Study information

• Verified date: September 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 our usual clinical practice, we noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1 sequence with gadolinium injection, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).

This contrast enhancement, could confirm the nerve impairment This study aims to analyse the efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not yet described in the literature, to depict this enhancement.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this 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). This new sequence 3D PD T1 sequence focused on the III could thus be systematically included in the usual MRI protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)

Exclusion Criteria:

-Absolute contraindication to MRI or injection of contrast agents.

Related Conditions & MeSH terms

• Ophthalmoplegia

Intervention

Device:
• 3D PD T1 MRI sequence
After MRI has been performed (about 5 minutes of additional time compared to the usual sequences), a double reading of the MRI will be performed by two radiologists (1 experienced and 1 junior).

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist)	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).	Baseline