Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT00248820
Status:
UNKNOWN
Last Update Posted:
2007-11-22
First Post:
2005-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-21', 'studyFirstSubmitDate': '2005-11-02', 'studyFirstSubmitQcDate': '2005-11-02', 'lastUpdatePostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time', 'timeFrame': 'inclusion period'}], 'secondaryOutcomes': [{'measure': 'Histology assessments: microvessel density assessments and histological diagnosis', 'timeFrame': 'inclusion period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contrast-enhanced Ultrasound', 'Ultrasound Contrast agent, microbubbles', 'Ovarian tumor', 'vascularization'], 'conditions': ['Ovarian Tumor']}, 'referencesModule': {'references': [{'pmid': '9263422', 'type': 'BACKGROUND', 'citation': 'Tailor A, Jurkovic D, Bourne TH, Collins WP, Campbell S. Sonographic prediction of malignancy in adnexal masses using multivariate logistic regression analysis. Ultrasound Obstet Gynecol. 1997 Jul;10(1):41-7. doi: 10.1046/j.1469-0705.1997.10010041.x.'}, {'pmid': '8654001', 'type': 'BACKGROUND', 'citation': 'MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. doi: 10.1016/s0009-9260(96)80155-3. No abstract available.'}, {'pmid': '10411796', 'type': 'BACKGROUND', 'citation': 'Timmerman D, Bourne TH, Tailor A, Collins WP, Verrelst H, Vandenberghe K, Vergote I. A comparison of methods for preoperative discrimination between malignant and benign adnexal masses: the development of a new logistic regression model. Am J Obstet Gynecol. 1999 Jul;181(1):57-65. doi: 10.1016/s0002-9378(99)70436-9.'}, {'pmid': '11110947', 'type': 'BACKGROUND', 'citation': 'Kinkel K, Hricak H, Lu Y, Tsuda K, Filly RA. US characterization of ovarian masses: a meta-analysis. Radiology. 2000 Dec;217(3):803-11. doi: 10.1148/radiology.217.3.r00dc20803.'}, {'pmid': '8001878', 'type': 'BACKGROUND', 'citation': 'Suren A, Osmers R, Kulenkampff D, Kuhn W. Visualization of blood flow in small ovarian tumor vessels by transvaginal color Doppler sonography after echo enhancement with injection of Levovist. Gynecol Obstet Invest. 1994;38(3):210-2. doi: 10.1159/000292481.'}, {'pmid': '11065267', 'type': 'BACKGROUND', 'citation': 'Orden MR, Gudmundsson S, Kirkinen P. Contrast-enhanced sonography in the examination of benign and malignant adnexal masses. J Ultrasound Med. 2000 Nov;19(11):783-8. doi: 10.7863/jum.2000.19.11.783.'}, {'pmid': '10639039', 'type': 'BACKGROUND', 'citation': 'Morel DR, Schwieger I, Hohn L, Terrettaz J, Llull JB, Cornioley YA, Schneider M. Human pharmacokinetics and safety evaluation of SonoVue, a new contrast agent for ultrasound imaging. Invest Radiol. 2000 Jan;35(1):80-5. doi: 10.1097/00004424-200001000-00009.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.\n\nBy using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions.\n\nThe intravascular contrast agent properties will be compared between benign and malignant adnexal masses.\n\nThe final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.', 'detailedDescription': 'SonoVue (Sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure and specifically designed to be used as a contrast agent for ultrasound imaging.\n\nStudy design : one contrast-enhanced ultrasonography is proposed before any surgery to patients with ovarian mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Patient with adnexal mass detected by ultrasound\n* Any programmed surgery\n\nExclusion Criteria:\n\n* Any contraindication to surgery\n* Injection of another contrast agent within 24 hours before the study examination\n* Pregnancy, breastfeeding\n* Patient known to have a coronary syndrome\n* Unstable angina and myocardial infarction\n* Acute cardiac failure, Class III/IV cardiac failure\n* Severe rhythm disorders\n* Acute endocarditis\n* Prosthetic valves\n* Patient previously having received an investigational drug within 30 days prior to admission into this study'}, 'identificationModule': {'nctId': 'NCT00248820', 'briefTitle': 'Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses', 'orgStudyIdInfo': {'id': 'CT02-OV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Contrast-enhanced ultrasound', 'type': 'PROCEDURE', 'description': 'Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Henri Marret, PR', 'role': 'CONTACT', 'email': 'marret@med.univ-tours.fr', 'phone': '(33) 0 47 47 82 59'}, {'name': 'François Tranquart, PR', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Henri Marret, PR', 'role': 'CONTACT', 'email': 'marret@med.univ-tours.fr', 'phone': '(33) 0 47 47 82 59'}], 'overallOfficials': [{'name': 'Henri Marret, PR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours'}, {'name': 'François Tranquart, PR', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre d'Innovation Technologique - CHRU Tours"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}}}}