Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Not Applicable

• Conditions: Ovarian Tumor

• Registration Number: NCT00248820
• Lead Sponsor: University Hospital, Tours

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-11-02
• Study First Submitted QC: 2005-11-02
• Study First Posted: 2005-11-04
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-21
• Last Update Posted: 2007-11-22
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 18 years of age or older
• Patient with adnexal mass detected by ultrasound
• Any programmed surgery

Exclusion Criteria

• Any contraindication to surgery
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time	inclusion period

Secondary Outcome Measures

Name	Time	Method
Histology assessments: microvessel density assessments and histological diagnosis	inclusion period

Trial Locations

Locations (1)

University Hospital of Tours; 🇫🇷 Tours, France