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Completed

NCT Number: NCT02434120

MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

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.

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Key information

Conditions

Orbital Tumor Bone Diseases Bone Neoplasms Eye Diseases Eye Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Orbital Diseases Orbital Neoplasms Skull Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation A De Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: PERFORM

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
May 5, 2015
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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