Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE) (PUCE)
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|ClinicalTrials.gov Identifier: NCT02678091|
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : December 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Tumor of the Orbit||Device: Ultrasound exam with Doppler||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contribution of the Quantitative Analysis of the Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)|
|Actual Study Start Date :||June 30, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Patients with an orbital mass
Device: Ultrasound exam with Doppler
Ultrasound exam of the orbit
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678091
|Contact: Laurence Salomon, MD, PhD||+33 1 48 03 64 31|
|Contact: Augustin Lecler, MD|
|Fondation ophtalmique Adolphe de Rothschild||Recruiting|
|Paris, France, 75019|
|Contact: Laurence Salomon, MD, PhD +33 1 48 03 64 31 firstname.lastname@example.org|