Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-30 @ 10:26 AM
Study NCT ID:
NCT00351494
Status:
UNKNOWN
Last Update Posted:
2007-11-22
First Post:
2006-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009214', 'term': 'Myoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-21', 'studyFirstSubmitDate': '2006-07-12', 'studyFirstSubmitQcDate': '2006-07-12', 'lastUpdatePostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the usefulness of contrast-enhanced ultrasound with real-time imaging technique in the assessment of vascular patterns from myomas myometrium and ovaries before and after uterine artery embolization', 'timeFrame': 'Inclusion period and follow-up'}], 'secondaryOutcomes': [{'measure': 'Accordance between contrast-enhanced imaging and IRM', 'timeFrame': 'inclusion period and follow-up'}, {'measure': 'Accordance between early vascular patterns due to embolization of the fibroma and the success of the technique which is evaluated after 6 month', 'timeFrame': 'inclusion period and follow-up'}, {'measure': 'Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium', 'timeFrame': 'inclusion period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['embolization', 'contrast enhanced ultrasound', 'myoma', 'uterine artery', 'microvascularisation'], 'conditions': ['Myoma']}, 'referencesModule': {'references': [{'pmid': '11851974', 'type': 'BACKGROUND', 'citation': 'Tranquart F, Brunereau L, Cottier JP, Marret H, Gallas S, Lebrun JL, Body G, Herbreteau D, Pourcelot L. Prospective sonographic assessment of uterine artery embolization for the treatment of fibroids. Ultrasound Obstet Gynecol. 2002 Jan;19(1):81-7. doi: 10.1046/j.0960-7692.2001.00535.x.'}, {'pmid': '15777445', 'type': 'BACKGROUND', 'citation': 'Marret H, Cottier JP, Alonso AM, Giraudeau B, Body G, Herbreteau D. Predictive factors for fibroids recurrence after uterine artery embolisation. BJOG. 2005 Apr;112(4):461-5. doi: 10.1111/j.1471-0528.2004.00487.x.'}, {'pmid': '14971005', 'type': 'BACKGROUND', 'citation': 'Marret H, Tranquart F, Sauget S, Alonso AM, Cottier JP, Herbreteau D. Contrast-enhanced sonography during uterine artery embolization for the treatment of leiomyomas. Ultrasound Obstet Gynecol. 2004 Jan;23(1):77-9. doi: 10.1002/uog.944.'}]}, 'descriptionModule': {'briefSummary': 'Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.', 'detailedDescription': 'Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure.\n\nMicrovascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women candidate for embolization of myomas', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Uterine myomas with solid tissue (greater diameter lower than 15 cm)\n* The embolization is planified during the 15 days after the contrast ultrasonography\n* Written informed consent is signed\n\nExclusion Criteria:\n\n* Intracavitary uterine mass possibly due to a polyp or endometrial cancer\n* Necessity of using the endovaginal way of ultrasonography because of the myoma's size and accessibility\n* Menopause\n* Pregnancy and breastfeeding\n* Recent cardiac affection\n* History of acute cardiac disease"}, 'identificationModule': {'nctId': 'NCT00351494', 'briefTitle': 'Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization', 'orgStudyIdInfo': {'id': 'HP06-HM/FIBROME'}}, 'armsInterventionsModule': {'interventions': [{'name': 'contrast enhanced ultrasonography', 'type': 'PROCEDURE', 'description': 'Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.\n\nAbdominal route 2.4 ml sonovue per injection / bolus'}, {'name': 'embolization', 'type': 'PROCEDURE', 'description': 'Intervention is described in the case report form for each patient'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37344', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Henri MARRET, Pr', 'role': 'CONTACT', 'email': 'marret@med.univ-tours.fr', 'phone': '(33) 2 47 47 82 59'}, {'name': 'Catherine ROUSSEL, ARC', 'role': 'CONTACT', 'email': 'roussel@med.univ-tours.fr', 'phone': '(33) 2 47 47 97 89'}, {'name': 'François TRANQUART, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aurore BLEUZEN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Denis HERBRETEAU, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marc LEGEAIS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nathalie WAGNER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Centre d'Innovation Technologique-Ultrasons", 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Henri MARRET, Pr', 'role': 'CONTACT', 'email': 'marret@med.univ-tours.fr', 'phone': '(33) 2 47 47 82 59'}, {'name': 'Catherine ROUSSEL, ARC', 'role': 'CONTACT', 'email': 'roussel@med.univ-tours.fr', 'phone': '(33) 2 47 47 97 89'}], 'overallOfficials': [{'name': 'Henri MARRET, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Gynécologie Obstétrique CHRU TOURS'}, {'name': 'François TRANQUART, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre d'Innovation Technologique CHRU TOURS"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}}}}