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

Not Applicable

Completed

• Conditions: Tumor of the Orbit
• Interventions: Device: Ultrasound exam with Doppler

• Registration Number: NCT02678091
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Study Start: 2016-06-30
• Primary Completion: 2023-06
• Study Completion: 2023-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Ultrasound exam with Doppler	Patients with an orbital mass

Primary Outcome Measures

Name	Time	Method
Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard	One month
Specificity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard	One month

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France