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Trial record 62 of 958 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

MRI and Orbital Tumours (MEDORT) (MEDORT)

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ClinicalTrials.gov Identifier: NCT02401906
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.


Condition or disease Intervention/treatment
Orbital Tumor Orbital Pseudotumor Other: MRI

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI for the Etiological Diagnosis of Orbital Tumours
Actual Study Start Date : May 27, 2015
Estimated Primary Completion Date : May 27, 2019
Estimated Study Completion Date : May 27, 2019



Primary Outcome Measures :
  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. [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401906


Contacts
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Contact: Laurence Salomon, MD, PhD +33 1 48 03 64 31 lsalomon@fo-rothschild.fr

Locations
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France
Fondation ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Augustin Lecler, MD       alecler@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02401906     History of Changes
Other Study ID Numbers: ALR_2015-8
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Orbital Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Eye Neoplasms
Bone Diseases
Orbital Pseudotumor
Musculoskeletal Diseases
Eye Diseases
Orbital Diseases