Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Tumor of the Orbit

Treatments: Device: Ultrasound exam with Doppler

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02678091

ALR_2015_40

Details and patient eligibility

About

Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

Quantitative analysis of the ultrasound exam with doppler of those masses could identify diagnostic criteria, especially for the lacrimal gland, easily explorable.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient aged 18 years or more
• with an orbital mass for which a biopsy and/or a surgical removal is planned
• before surgery or biopsy

Exclusion criteria

• pregnancy
• breast feeding
• patient under a legal protection procedure
• patient denying to participate to the study
• lack of affiliation to a social security system

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Patients

Experimental group

Description:

Patients with an orbital mass

Treatment:

Device: Ultrasound exam with Doppler