MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

Orbital Tumor Clinical Trial

— PERFORM  

Official title:

Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434120
• Other study ID #: ALR_2015_13
• Status: Completed
• Start date: November 2015
• Est. completion date: August 8, 2022

Study information

• Verified date: April 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orbital Tumor

Locations

Country	Name	City	State
France	Fondation A De Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

References & 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 Neu — View Citation

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. Onl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient		one month