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

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.

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Key information

Conditions

Tumor of the Orbit Bone Diseases Bone Neoplasms Eye Diseases Eye Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Orbital Diseases Orbital Neoplasms Skull Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound exam with Doppler

Device

Ultrasound exam of the orbit

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: PUCE

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2023
First posted: Feb 9, 2016
Registry last updated: Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed