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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 : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date December 1, 2020
Actual Study Start Date  ICMJE June 30, 2016
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)
Official Title  ICMJE Contribution of the Quantitative Analysis of the Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Tumor of the Orbit
Intervention  ICMJE Device: Ultrasound exam with Doppler
Ultrasound exam of the orbit
Study Arms  ICMJE Experimental: Patients
Patients with an orbital mass
Intervention: Device: Ultrasound exam with Doppler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurence Salomon, MD, PhD +33 1 48 03 64 31
Contact: Augustin Lecler, MD
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678091
Other Study ID Numbers  ICMJE ALR_2015_40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor  ICMJE Fondation Ophtalmologique Adolphe de Rothschild
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP