MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)
PERFORM
Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors
1 other identifier
observational
238
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedApril 16, 2024
April 1, 2024
6.8 years
April 30, 2015
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient
one month
Eligibility Criteria
Patients undergoing a MRI because of an orbital mass
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation A De Rothschild
Paris, 75019, France
Related Publications (2)
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.
PMID: 38453407RESULTO'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 Oct 1;59(10):737-745. doi: 10.1097/RLI.0000000000001076. Epub 2024 Apr 11.
PMID: 38597586RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 5, 2015
Study Start
November 1, 2015
Primary Completion
August 8, 2022
Study Completion
August 8, 2022
Last Updated
April 16, 2024
Record last verified: 2024-04