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

NCT ID: NCT02678091

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2023-06-30

Brief Summary

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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 Description

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Conditions

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Tumor of the Orbit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Patients with an orbital mass

Group Type EXPERIMENTAL

Ultrasound exam with Doppler

Intervention Type DEVICE

Ultrasound exam of the orbit

Interventions

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Ultrasound exam with Doppler

Ultrasound exam of the orbit

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation ophtalmique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ALR_2015_40

Identifier Type: -

Identifier Source: org_study_id