Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-11 @ 1:29 PM
Study NCT ID:
NCT04104802
Status:
WITHDRAWN
Last Update Posted:
2020-02-25
First Post:
2019-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010307', 'term': 'Parotid Neoplasms'}], 'ancestors': [{'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'refusal of the ansm', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve.', 'timeFrame': '1 day', 'description': 'Sensitivity of new MRI sequences to determine whether the parotid tumor is in contact or at a distance from the facial nerve (common core and first division branches) in comparison with the intra-operative examination (gold standard).\n\nThe contact between the parotid tumor and the trunk of the facial nerve or its first branches of division is a binary qualitative variable with modalities defined as:\n\n* "Yes": tumor on contact (distance between the tumor and the trunk of the facial nerve or its first branches between 0 and 5 mm)\n* "No": trunk of the facial nerve or its first divisional branches located at a distance (ie more than 5mm from the parotid tumor).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parotid Tumor']}, 'descriptionModule': {'briefSummary': 'Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure', 'detailedDescription': '1. st visit: Inclusion, parotid MRI 3Tesla high resolution with specific sequences and gadolinium injection performed at the A. de Rothschild Foundation. Evaluation by two radiologists of the exact position of the parotid tumor with respect to the trunk of the facial nerve and its first branches, classified into two categories: contact (≤ 5 mm) or distance (\\> 5 mm).\n2. nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as those collected by the radiologists after the MRI. The surgeon will not be aware of the data concerning the ratios of parotid tumor to facial nerve collected on MRI sequences for research purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient candidate for first-line surgery for a parotid tumor', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old\n* Patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant)\n* Parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation\n* Patient affiliated or beneficiary of a social security scheme\n* Written consent to participate in the study\n\nExclusion Criteria:\n\n* Personal history of ipsilateral parotid surgery\n* Contraindication to MRI (electronic device, metallic foreign body, claustrophobia)\n* Known hypersensitivity to gadolinium contrast agents\n* Renal impairment known: glomerular filtration rate \\<30 mL / min\n* Pre or post-operative period of liver transplantation\n* Patient benefiting from a legal protection measure\n* Pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT04104802', 'acronym': 'FACPAR', 'briefTitle': 'Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors', 'orgStudyIdInfo': {'id': 'ACN_2019_12'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'All patients included will benefit from both methods of assessing anatomical relationships between the facial nerve and the parotid tumor:\n\n1\\) New medical imaging technique evaluated: 3 Tesla Parotidic MRI High Resolution with Specific Sequences and Gadolinium Injection 2) Standard Gold: Intraoperative Exam'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Fondation Adolphe De Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Institut Arthur Vernes', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital FOCH', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}