Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-03 @ 12:17 PM
Study NCT ID:
NCT02694406
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Perfusion in Adnexal Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098642', 'term': 'Perfusion Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detect the number of malignant adnexal masses', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diagnosis'], 'conditions': ['Complex Adnexal Masses']}, 'descriptionModule': {'briefSummary': 'As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide number of immature microvessels. These vessels are characterized by a lack of coverage by pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio pathogenic characteristics have been demonstrated to be in line with variations of MR perfusion parameters.\n\nUnlike many lesions that occur in other parts of the body, biopsy should not be performed in adnexal masses that demonstrate no evidence of peritoneal disease because it may cause spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have been a malignant tumor that was limited.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with adenxal masses', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complex adnexal mass\n* patient fit for surgery\n\nExclusion Criteria:\n\n* any general contraindication to MRI\n* severely ill patients\n* those with claustrophobia.'}, 'identificationModule': {'nctId': 'NCT02694406', 'acronym': 'MRI-CAM', 'briefTitle': 'MRI Perfusion in Adnexal Masses', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Added Value of MRI Perfusion in Evaluation of Complex Adnexal Masses', 'orgStudyIdInfo': {'id': 'MRI-CAM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI perfusion', 'type': 'DEVICE', 'description': 'contrast-enhanced MR imaging including perfusion weighted imaging (PWI)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}, {'city': 'Asyut', 'country': 'Egypt', 'facility': 'Ahmed Abbas', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}