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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

Primary Purpose

Ovarian Tumor

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Contrast-enhanced ultrasound
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Tumor focused on measuring Contrast-enhanced Ultrasound, Ultrasound Contrast agent, microbubbles, Ovarian tumor, vascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of ToursRecruiting

Outcomes

Primary Outcome Measures

From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time

Secondary Outcome Measures

Histology assessments: microvessel density assessments and histological diagnosis

Full Information

First Posted
November 2, 2005
Last Updated
November 21, 2007
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT00248820
Brief Title
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

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Tumor
Keywords
Contrast-enhanced Ultrasound, Ultrasound Contrast agent, microbubbles, Ovarian tumor, vascularization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Contrast-enhanced ultrasound
Intervention Description
Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).
Primary Outcome Measure Information:
Title
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
Time Frame
inclusion period
Secondary Outcome Measure Information:
Title
Histology assessments: microvessel density assessments and histological diagnosis
Time Frame
inclusion period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henri Marret, PR
Phone
(33) 0 47 47 82 59
Email
marret@med.univ-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri Marret, PR
Organizational Affiliation
Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Tranquart, PR
Organizational Affiliation
Centre d'Innovation Technologique - CHRU Tours
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri Marret, PR
Phone
(33) 0 47 47 82 59
Email
marret@med.univ-tours.fr
First Name & Middle Initial & Last Name & Degree
François Tranquart, PR

12. IPD Sharing Statement

Citations:
PubMed Identifier
9263422
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.
Results Reference
background
PubMed Identifier
8654001
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.
Results Reference
background
PubMed Identifier
10411796
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.
Results Reference
background
PubMed Identifier
11110947
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.
Results Reference
background
PubMed Identifier
8001878
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.
Results Reference
background
PubMed Identifier
11065267
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. Erratum In: J Ultrasound Med 2001 Jan;20(1):20.
Results Reference
background
PubMed Identifier
10639039
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.
Results Reference
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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

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