Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
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|ClinicalTrials.gov Identifier: NCT00248820|
Recruitment Status : Unknown
Verified November 2007 by University Hospital, Tours.
Recruitment status was: Recruiting
First Posted : November 4, 2005
Last Update Posted : November 22, 2007
This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Tumor||Procedure: Contrast-enhanced ultrasound||Not Applicable|
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.
Study design : one contrast-enhanced ultrasonography is proposed before any surgery to patients with ovarian mass.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses|
|Study Start Date :||September 2002|
|Estimated Study Completion Date :||February 2009|
- Procedure: Contrast-enhanced ultrasound
Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).
- From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time [ Time Frame: inclusion period ]
- Histology assessments: microvessel density assessments and histological diagnosis [ Time Frame: inclusion period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248820
|Contact: Henri Marret, PR||(33) 0 47 47 82 firstname.lastname@example.org|
|University Hospital of Tours||Recruiting|
|Tours, France, 37044|
|Contact: Henri Marret, PR (33) 0 47 47 82 59 email@example.com|
|Sub-Investigator: François Tranquart, PR|
|Principal Investigator:||Henri Marret, PR||Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours|
|Study Director:||François Tranquart, PR||Centre d'Innovation Technologique - CHRU Tours|