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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

Ovarian Tumor

Treatments

Procedure: Contrast-enhanced ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT00248820
CT02-OV

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Henri Marret, PR

Data sourced from clinicaltrials.gov

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