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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 : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.


Condition or disease Intervention/treatment Phase
Tumor of the Orbit Device: Ultrasound exam with Doppler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Patients
Patients with an orbital mass
Device: Ultrasound exam with Doppler
Ultrasound exam of the orbit




Primary Outcome Measures :
  1. Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard [ Time Frame: One month ]
  2. Specificity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard [ Time Frame: One month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Laurence Salomon, MD, PhD +33 1 48 03 64 31
Contact: Augustin Lecler, MD

Locations
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France
Fondation ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence Salomon, MD, PhD    +33 1 48 03 64 31    lsalomon@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02678091    
Other Study ID Numbers: ALR_2015_40
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Orbital Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Eye Neoplasms
Bone Diseases
Musculoskeletal Diseases
Eye Diseases
Orbital Diseases