Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by University Hospital, Tours.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Hospital, Tours

ClinicalTrials.gov Identifier:

NCT00248820

First received: November 2, 2005

Last updated: November 21, 2007

Last verified: November 2007

History of Changes

Purpose

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.

Condition	Intervention
Ovarian Tumor	Procedure: Contrast-enhanced ultrasound

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Histology assessments: microvessel density assessments and histological diagnosis [ Time Frame: inclusion period ]

Estimated Enrollment:	100
Study Start Date:	September 2002
Estimated Study Completion Date:	February 2009

Intervention Details:

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248820

Contacts

Contact: Henri Marret, PR

(33) 0 47 47 82 59

marret@med.univ-tours.fr

Locations

France
University Hospital of Tours	Recruiting
Tours, France, 37044
Contact: Henri Marret, PR (33) 0 47 47 82 59 marret@med.univ-tours.fr
Sub-Investigator: François Tranquart, PR

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:	Henri Marret, PR	Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours
Study Director:	François Tranquart, PR	Centre d'Innovation Technologique - CHRU Tours

More Information

Publications:

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.

MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. Review. No abstract available.

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.

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.

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.

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. Erratum in: J Ultrasound Med 2001 Jan;20(1):20.

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.

ClinicalTrials.gov Identifier:	NCT00248820 History of Changes
Other Study ID Numbers:	CT02-OV
Study First Received:	November 2, 2005
Last Updated:	November 21, 2007
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:

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

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 22, 2013

To Top