Clinical trial NCT00248820: Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
Official title: Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Tumor
Keywords: Contrast-enhanced Ultrasound
Ultrasound Contrast agent, microbubbles
Ovarian tumor
vascularization
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
timeFrame: inclusion period
Secondary outcomes:
measure: Histology assessments: microvessel density assessments and histological diagnosis
timeFrame: inclusion period
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours
name: Henri Marret, PR
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Innovation Technologique - CHRU Tours
name: François Tranquart, PR
role: STUDY_DIRECTOR
References:
citation: Tailor A, Jurkovic D, Bourne TH, Collins WP, Campbell S. Sonographic prediction of malignancy in adnexal masses using multivariate logistic regression analysis. Ultrasound Obstet Gynecol. 1997 Jul;10(1):41-7. doi: 10.1046/j.1469-0705.1997.10010041.x.
citation: MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. doi: 10.1016/s0009-9260(96)80155-3. No abstract available.
citation: Timmerman D, Bourne TH, Tailor A, Collins WP, Verrelst H, Vandenberghe K, Vergote I. A comparison of methods for preoperative discrimination between malignant and benign adnexal masses: the development of a new logistic regression model. Am J Obstet Gynecol. 1999 Jul;181(1):57-65. doi: 10.1016/s0002-9378(99)70436-9.
citation: Kinkel K, Hricak H, Lu Y, Tsuda K, Filly RA. US characterization of ovarian masses: a meta-analysis. Radiology. 2000 Dec;217(3):803-11. doi: 10.1148/radiology.217.3.r00dc20803.
citation: Suren A, Osmers R, Kulenkampff D, Kuhn W. Visualization of blood flow in small ovarian tumor vessels by transvaginal color Doppler sonography after echo enhancement with injection of Levovist. Gynecol Obstet Invest. 1994;38(3):210-2. doi: 10.1159/000292481.
citation: Orden MR, Gudmundsson S, Kirkinen P. Contrast-enhanced sonography in the examination of benign and malignant adnexal masses. J Ultrasound Med. 2000 Nov;19(11):783-8. doi: 10.7863/jum.2000.19.11.783.
citation: Morel DR, Schwieger I, Hohn L, Terrettaz J, Llull JB, Cornioley YA, Schneider M. Human pharmacokinetics and safety evaluation of SonoVue, a new contrast agent for ultrasound imaging. Invest Radiol. 2000 Jan;35(1):80-5. doi: 10.1097/00004424-200001000-00009.