MRI and Orbital Tumours (MEDORT)

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.

The MRI assessment performed routinely in a patient with an orbital mass includes morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of Gadobutrol®).

In this research protocol, during the injection of the contrast agent performed during the MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition will be preceded by two short series for calibration. The post treatment will include parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. It will also be added a magnetic susceptibility EPI sequence type. All the qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected.

The result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.

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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 Orbital Pseudotumor Skull Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation ophtalmique Adolphe 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 over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an MRI, before any surgical treatment

Exclusion criteria

Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
Patient under guardianship
Patient not willing to participate.
Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
Motion artifact on the sequences, not corrected by the repeat sequences
Metal artifact prohibiting the analysis of the region of interest
Biopsy or resection not performed, particularly if the orbital mass is due to an infection
MRI findings allowing a diagnosis without the need for pathology

Treatment and study plan

MRI

Other

Primary outcomes

Sensitivity and specificity based on the patterns of the intra voxel incoherent motion, the dynamic susceptibility contrast and enhancement, for distinguishing orbital tumors from orbital pseudotumor, the gold standard being the pathological exam.

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

MRI for the Etiological Diagnosis of Orbital Tumours

Acronym: MEDORT

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Mar 30, 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.

Published trials that share one or more normalized conditions with this study.

Completed