Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00248820

Enrollment

100

Registered

2005-11-04

Start date

2002-09-30

Completion date

2009-02-28

Last updated

2007-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Tumor

Keywords

Contrast-enhanced Ultrasound, Ultrasound Contrast agent, microbubbles, Ovarian tumor, vascularization

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.

Interventions

PROCEDUREContrast-enhanced ultrasound

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Histology assessments: microvessel density assessments and histological diagnosis	inclusion period

Countries

France

Contacts

Primary ContactHenri Marret, PR

marret@med.univ-tours.fr(33) 0 47 47 82 59

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026