Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT02401906
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2015-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI and Orbital Tumours (MEDORT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009918', 'term': 'Orbital Neoplasms'}, {'id': 'D016727', 'term': 'Orbital Pseudotumor'}], 'ancestors': [{'id': 'D012888', 'term': 'Skull Neoplasms'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009916', 'term': 'Orbital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orbital Tumor', 'Orbital Pseudotumor']}, 'referencesModule': {'references': [{'pmid': '38597586', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nPathology 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.\n\nThe 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.\n\nThe 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®).\n\nIn 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.\n\nThe result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)\n* Patient under guardianship\n* Patient not willing to participate.\n* Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)\n* Motion artifact on the sequences, not corrected by the repeat sequences\n* Metal artifact prohibiting the analysis of the region of interest\n* Biopsy or resection not performed, particularly if the orbital mass is due to an infection\n* MRI findings allowing a diagnosis without the need for pathology'}, 'identificationModule': {'nctId': 'NCT02401906', 'acronym': 'MEDORT', 'briefTitle': 'MRI and Orbital Tumours (MEDORT)', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'MRI for the Etiological Diagnosis of Orbital Tumours', 'orgStudyIdInfo': {'id': 'ALR_2015-8'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation ophtalmique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}