Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-03 @ 3:53 AM
Study NCT ID:
NCT03893812
Status:
UNKNOWN
Last Update Posted:
2019-03-28
First Post:
2019-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Color Doppler and Mri Diffusion in Major Salivary Gland Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses', 'timeFrame': 'baseline', 'description': 'The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses will differ according to the nature of the mass determined by histopathological finding'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Salivary Gland Diseases']}, 'descriptionModule': {'briefSummary': 'This study intend to evaluate the combined value of ADC and COLOR DOPPLER in differentiating benign and malignant salivary gland tumors in comparison to histopathological findings and its use in preoperative prediction of benign and malignant masses.', 'detailedDescription': 'the study aim to achieve preoperative differentiation between benign and malignant masses of the major salivary glands using the ADC values and Color Doppler values (PSV - PI - RI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a suspicious swelling in major salivary glands.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands.\n\nExclusion Criteria:\n\n1. Patients with history of metal plates or screws or artificial joints.\n2. Patients who have phobia of indoor places.\n3. Patients with contraindication to MRI like intra-cerebral aneurysmal clips, cardiac pacemaker, and metallic foreign body at region of examination.'}, 'identificationModule': {'nctId': 'NCT03893812', 'briefTitle': 'Color Doppler and Mri Diffusion in Major Salivary Gland Masses', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Combined Role of Color Doppler and Diffusion Weighted MRI In Differentiation Between Benign and Malignant Tumors of Major Salivary Glands', 'orgStudyIdInfo': {'id': 'doppler & MRdiffusion salivary'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'diffusion weighted MR'}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Color Doppler ultrasound'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed AH Alam El-Din, Doctor', 'role': 'CONTACT', 'email': 'mohamedalam03@gmail.com', 'phone': '01093900515'}, {'name': 'Radwa KA Abd El-Naser, MD', 'role': 'CONTACT', 'email': 'radwa.soliman@yahoo.co.ek', 'phone': '01009910070'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Ahmed Alam El-Din', 'investigatorAffiliation': 'Assiut University'}}}}