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MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02434120
Acronym
PERFORM
Enrollment
238
Registered
2015-05-05
Start date
2015-11-30
Completion date
2022-08-08
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital Tumor

Keywords

MRI, Orbital neoplasm

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.

Interventions

None listed

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Concordance of the MRI type and the pathological findings as assessed by the kappa coefficientone month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026