MRI and Orbital Tumours (MEDORT)

NCT02401906 | Completed

• 1 other identifier: ALR_2015-8
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Orbital Tumor; Orbital Pseudotumor

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Interventions

MRI OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 38597586 RESULT

MeSH Terms

Conditions

Orbital Neoplasms; Orbital Pseudotumor

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 30, 2015
• Study Start: May 27, 2015
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

FR (1)