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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Current Primary Outcome:

  • Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard [ Time Frame: One month ]
  • Specificity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard [ Time Frame: One month ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fondation Ophtalmologique Adolphe de Rothschild

Dates:
Date Received: February 4, 2016
Date Started: February 2016
Date Completion: October 2019
Last Updated: September 7, 2016
Last Verified: September 2016