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

Tumor of the Orbit Clinical Trial

— PUCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678091
• Other study ID #: ALR_2015_40
• Status: Completed
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: June 2023

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tumor of the Orbit

Intervention

Device:
• Ultrasound exam with Doppler
Ultrasound exam of the orbit

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe 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	Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard		One month
Primary	Specificity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard		One month