Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Ovarian Tumor Clinical Trial

Official title:

Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00248820
• Other study ID #: CT02-OV
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2005
• Last updated: November 21, 2007
• Start date: September 2002
• Est. completion date: February 2009

Study information

• Verified date: November 2007
• Source: University Hospital, Tours
• Contact: Henri Marret, PR
• Phone: (33) 0 47 47 82 59
• Email: marret[@]med.univ-tours.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovarian Tumor

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. Review. — View 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. — View Citation

Ordén 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. Erratum in: J Ultrasound Med 2001 Jan;20(1):20. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time		inclusion period
Secondary	Histology assessments: microvessel density assessments and histological diagnosis		inclusion period