Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
NCT ID: NCT00248820
Last Updated: 2007-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2002-09-30
2009-02-28
Brief Summary
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By 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.
The intravascular contrast agent properties will be compared between benign and malignant adnexal masses.
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.
Detailed Description
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Study design : one contrast-enhanced ultrasonography is proposed before any surgery to patients with ovarian mass.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Contrast-enhanced ultrasound
Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).
Eligibility Criteria
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Inclusion Criteria
* Patient with adnexal mass detected by ultrasound
* Any programmed surgery
Exclusion Criteria
* Injection of another contrast agent within 24 hours before the study examination
* Pregnancy, breastfeeding
* Patient known to have a coronary syndrome
* Unstable angina and myocardial infarction
* Acute cardiac failure, Class III/IV cardiac failure
* Severe rhythm disorders
* Acute endocarditis
* Prosthetic valves
* Patient previously having received an investigational drug within 30 days prior to admission into this study
18 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Principal Investigators
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Henri Marret, PR
Role: PRINCIPAL_INVESTIGATOR
Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours
François Tranquart, PR
Role: STUDY_DIRECTOR
Centre d'Innovation Technologique - CHRU Tours
Locations
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University Hospital of Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Henri Marret, PR
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CT02-OV
Identifier Type: -
Identifier Source: org_study_id