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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

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ClinicalTrials.gov Identifier: NCT00248820
Recruitment Status : Unknown
Verified November 2007 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : November 4, 2005
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:
University Hospital, Tours

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.


Condition or disease Intervention/treatment Phase
Ovarian Tumor Procedure: Contrast-enhanced ultrasound Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
Study Start Date : September 2002
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources


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


Primary Outcome Measures :
  1. 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 :
  1. Histology assessments: microvessel density assessments and histological diagnosis [ Time Frame: inclusion period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00248820     History of Changes
Other Study ID Numbers: CT02-OV
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007

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