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Ovarian TumorNCT00248820

Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

A study testing Contrast-enhanced ultrasound in people with Ovarian Tumor, run by University Hospital, Tours at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Tumor
What is being tested?
Contrast-enhanced ultrasound
How many people
100 participants
Where
1 siteFrance
Study dates
Sep 2002to Feb 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Patient with adnexal mass detected by ultrasound
  • Any programmed surgery

Who cannot join

  • 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
Show all 10Show fewer
  • Severe rhythm disorders
  • Acute endocarditis
  • Prosthetic valves
  • Patient previously having received an investigational drug within 30 days prior to admission into this study

Trial locations and contacts

1 site in 1 country.

Henri Marret, PR contact

(33) 0 47 47 82 59

marret@med.univ-tours.fr

France1 site, 1 recruiting

  • University Hospital of Tours

    Tours, 37044

    Henri Marret, PR, (33) 0 47 47 82 59, marret@med.univ-tours.fr

    François Tranquart, PR

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Conditions
Ovarian Tumor
Being tested
Contrast-enhanced ultrasound
Keywords
Contrast-enhanced Ultrasound, Ultrasound Contrast agent, microbubbles, Ovarian tumor, vascularization
Medical subject headings
Ovarian Neoplasms, Neovascularization, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast-enhanced ultrasoundProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: inclusion period

Secondary outcomes (1)

  1. Histology assessments: microvessel density assessments and histological diagnosis

    Measured: inclusion period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2005 (estimated)
  2. Study startSep 2002
  3. Study completionFeb 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248820
Sponsor's protocol ID
CT02-OV
Status last verified
Nov 2007
First submitted
2 Nov 2005
Last updated
22 Nov 2007
Results posted
No
Data monitoring committee
No

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. doi: 10.1046/j.1469-0705.1997.10010041.x.

    PubMed 9263422

  • 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.

    PubMed 8654001

  • 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.

    PubMed 10411796

  • 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.

    PubMed 11110947

  • 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.

    PubMed 8001878

  • 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.

    PubMed 11065267

  • 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.

    PubMed 10639039

Questions about this trial

What is this clinical trial studying?

A study testing Contrast-enhanced ultrasound in people with Ovarian Tumor, run by University Hospital, Tours at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Henri Marret, PR ((33) 0 47 47 82 59, marret@med.univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time (time frame: inclusion period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00248820, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2007.

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