Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease
NCT ID: NCT03690908
Last Updated: 2018-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2016-03-01
2016-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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IgG4-related orbital inflammation
patients with orbital inflammation and positive IgG4 immunostaining in orbital biopsy
no intervention (descriptive study)
no intervention (descriptive study)
non IgG4-related orbital inflammation
patients with orbital inflammation and negative IgG4 immunostaining in orbital biopsy
no intervention (descriptive study)
no intervention (descriptive study)
Interventions
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no intervention (descriptive study)
no intervention (descriptive study)
Eligibility Criteria
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Inclusion Criteria
* Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia.
* The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate.
* Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4.
Exclusion Criteria
* Histologically proven lymphoma
* Pretherapeutic MRI that is insufficient for an adequate interpretation
* Absence of IgG4 testing in the pathology examination
18 Years
ALL
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Locations
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Fondation Ophtalmologique A. de Rotchschild
Paris, , France
Countries
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Other Identifiers
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NI_2016_1_ALR
Identifier Type: -
Identifier Source: org_study_id
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