- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434120
MRI Perfusion Curves Typology and Orbital Tumors (PERFORM) (PERFORM)
Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75019
- Fondation A De Rothschild
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient
Time Frame: one month
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one month
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Collaborators and Investigators
Publications and helpful links
General Publications
- O'Shaughnessy E, Cossec CL, Mambour N, Lecoeuvre A, Savatovsky J, Zmuda M, Duron L, Lecler A. Diagnostic Performance of Dynamic Contrast-Enhanced 3T MR Imaging for Characterization of Orbital Lesions: Validation in a Large Prospective Study. AJNR Am J Neuroradiol. 2024 Mar 7;45(3):342-350. doi: 10.3174/ajnr.A8131.
- O'Shaughnessy E, Senicourt L, Mambour N, Savatovsky J, Duron L, Lecler A. Toward Precision Diagnosis: Machine Learning in Identifying Malignant Orbital Tumors With Multiparametric 3 T MRI. Invest Radiol. 2024 Apr 11. doi: 10.1097/RLI.0000000000001076. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALR_2015_13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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