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.|
|ClinicalTrials.gov Identifier: NCT02434120|
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : March 5, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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, 2019|
|Estimated Study Completion Date :||December 8, 2020|
- Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient [ Time Frame: one month ]
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): NCT02434120
|Fondation A De Rothschild||Recruiting|
|Paris, France, 75019|
|Contact: Augustin Lecler firstname.lastname@example.org|