Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01468402
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2011-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-12-27', 'releaseDate': '2011-11-15'}, {'resetDate': '2014-04-07', 'releaseDate': '2014-03-03'}], 'estimatedResultsFirstSubmitDate': '2011-11-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-10-23', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leiomyoma reduction in patients who underwent uterine artery embolization', 'timeFrame': 'One month before(baseline) and six month after the embolization', 'description': 'Use the magnetic resonanse to evaluate factors that predicted leiomyoma reduction in patients who underwent uterine artery embolization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leiomyoma', 'uterine artery embolization', 'magnetic resonance imaging'], 'conditions': ['Exposure to Magnetic Field', 'Uterine Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '20305945', 'type': 'BACKGROUND', 'citation': 'Affonso BB, Nasser F, de Jesus Silva SG, Silva MC, Zlotnik E, de Lorenzo Messina M, Baracat EC. [Strategies for reduction of exposure to ionizing radiation in women undergone to uterine fibroid embolization]. Rev Bras Ginecol Obstet. 2010 Feb;32(2):77-81. Portuguese.'}, {'pmid': '21271163', 'type': 'BACKGROUND', 'citation': 'Nasser F, Affonso BB, de Jesus-Silva SG, Coelho Dde O, Zlotnik E, Messina Mde L, Baracat EC. [Uterine fibroid embolization in women with giant fibroids]. Rev Bras Ginecol Obstet. 2010 Nov;32(11):530-5. doi: 10.1590/s0100-72032010001100003. Portuguese.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.', 'detailedDescription': 'This study followed symptomatic premenopausal women with uterine leiomyoma who underwent uterine artery embolization (UAE). Treatment was accompanied by magnetic resonance imaging of both the volume of the entire uterus and the leiomyomas one month before and six months after UAE. This patients were treated at the Uterine Leiomyoma Sector of the Department of Obstetrics and Gynecology, Medicine College of the University of São Paulo. In this study, the investigators examined 179 leiomyomas in 50 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women from the Leiomyoma Service, with eligible criteria and chose this kind of treatment between september 2008 and march 2009.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ultrasound diagnosis of uterine leiomyoma\n* presence of symptoms (menorrhalgia and/or pelvic pain)\n* indication for UAE(the desire to keep the uterus and/or contraindications for surgery).\n\nExclusion Criteria:\n\n* malignant genital neoplasms\n* pelvic inflammatory disease\n* allergy to iodinated contrast\n* coagulopathy, renal failure\n* vasculitis\n* pelvic irradiation\n* pregnancy\n* subserosal leiomyoma with a pedicle smaller than 50% of diameter of the fibroid.'}, 'identificationModule': {'nctId': 'NCT01468402', 'briefTitle': 'Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma', 'orgStudyIdInfo': {'id': 'HIAE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Magnetic Resonanse Image', 'description': 'The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroid, and their location in the myometrium was classified. Perfusion and the characterization of the T2 signal were also evaluated.', 'interventionNames': ['Procedure: Magnetic Resonance Image']}], 'interventions': [{'name': 'Magnetic Resonance Image', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance Image with a high-field scanner', 'Siemens Magnetom 3-Tesla'], 'description': 'The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.', 'armGroupLabels': ['Magnetic Resonanse Image']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05652 - 900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Eduardo Zlotnik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Israelita Albert Einstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eduardo Zlotnik', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-11-15', 'type': 'RELEASE'}, {'date': '2011-12-27', 'type': 'RESET'}, {'date': '2014-03-03', 'type': 'RELEASE'}, {'date': '2014-04-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eduardo Zlotnik, Principal Investigator, Hospital Israelita Albert Einstein'}}}}