Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease

IgG4-related Disease Clinical Trial

— RetroG4  

Official title:

Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690908
• Other study ID #: NI_2016_1_ALR
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: September 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015

• 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 :

• Clinical and biological signs of thyroid-associated orbitopathy

• Histologically proven lymphoma

• Pretherapeutic MRI that is insufficient for an adequate interpretation

• Absence of IgG4 testing in the pathology examination

Related Conditions & MeSH terms

• IgG4-related Disease
• Inflammation
• Orbital Infections, Inflammations and Irritations

Intervention

Other:
• no intervention (descriptive study)
no intervention (descriptive study)

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rotchschild	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	Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging		Within 2 weeks after the first consultation for orbital inflammation