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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

18 Years
Open (Enrolling)
Ovarian Tumor

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Trial Information

Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

inclusion period

Principal Investigator

Henri Marret, PR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2002

Completion Date:

February 2009

Related Keywords:

  • Ovarian Tumor
  • Contrast-enhanced Ultrasound
  • Ultrasound Contrast agent, microbubbles
  • Ovarian tumor
  • vascularization
  • Ovarian Neoplasms