Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ovarian Tumor
- Sponsor
- University Hospital, Tours
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
Time Frame: inclusion period
Secondary Outcomes
- Histology assessments: microvessel density assessments and histological diagnosis(inclusion period)