MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

NCT ID: NCT02434120

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

238 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2022-08-08

Brief Summary

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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.

Detailed Description

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Conditions

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Orbital Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation A De Rothschild

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 38453407 (View on PubMed)

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 Oct 1;59(10):737-745. doi: 10.1097/RLI.0000000000001076. Epub 2024 Apr 11.

Reference Type RESULT
PMID: 38597586 (View on PubMed)

Other Identifiers

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ALR_2015_13

Identifier Type: -

Identifier Source: org_study_id

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