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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678091
Acronym
PUCE
Enrollment
124
Registered
2016-02-09
Start date
2016-06-30
Completion date
2023-06-30
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor of the Orbit

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.

Interventions

Ultrasound exam of the orbit

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standardOne month
Specificity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standardOne month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026