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MRI Perfusion Curves Typology and Orbital Tumors (PERFORM) (PERFORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02434120
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : February 25, 2020
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.

For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors.

In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.

Condition or disease
Orbital Tumor

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 8, 2021
Estimated Study Completion Date : December 8, 2021

Primary Outcome Measures :
  1. Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing a MRI because of an orbital mass

Inclusion Criteria:

  • Patient aged 18 years or more
  • with orbital mass for which a biopsy and/or a surgical removal is planned
  • undergoing an MRI
  • before surgery

Exclusion Criteria:

  • contra-indication to MRI
  • intolerance to constrast agent
  • 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 identifier (NCT number): NCT02434120

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Fondation A De Rothschild Recruiting
Paris, France, 75019
Contact: Augustin Lecler   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02434120    
Other Study ID Numbers: ALR_2015_13
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Orbital neoplasm
Additional relevant MeSH terms:
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Orbital Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Eye Neoplasms
Bone Diseases
Musculoskeletal Diseases
Eye Diseases
Orbital Diseases