Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Conditions
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Ovarian Tumor

Intervention / Treatment
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* Procedure: Contrast-enhanced ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Contrast-enhanced ultrasound|Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time |  | inclusion period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histology assessments: microvessel density assessments and histological diagnosis |  | inclusion period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast-enhanced Ultrasound, Ultrasound Contrast agent, microbubbles, Ovarian tumor, vascularization