Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

November 21, 2007 updated by: University Hospital, Tours

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Tours, France, 37044
        • Recruiting
        • University Hospital of Tours
        • Contact:
        • Sub-Investigator:
          • François TRANQUART, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

November 2, 2005

First Submitted That Met QC Criteria

November 2, 2005

First Posted (Estimate)

November 4, 2005

Study Record Updates

Last Update Posted (Estimate)

November 22, 2007

Last Update Submitted That Met QC Criteria

November 21, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT02-OV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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