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Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 28, 2008
Last updated: August 11, 2009
Last verified: October 2008

RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer.

PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary.

Condition Intervention
Ovarian Cancer
Drug: perflutren lipid microspheres
Other: medical chart review

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ovarian microvascularity

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine whether use of a contrast agent improves the images of the ovaries during ultrasonography.

OUTLINE: This is a multicenter study.

Patients may undergo baseline transabdominal or transvaginal ultrasonography, if not already done. Patients then undergo contrast-enhanced transabdominal or transvaginal ultrasonography using perflutren lipid microspheres (Definity®) IV.

Pathology reports from tissue collected during subsequent oophorectomy is analyzed and compared with ultrasonography findings.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of adnexal mass
  • Scheduled to undergo surgical oophorectomy


  • Not pregnant or nursing
  • Negative pregnancy test
  • No known respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
  • No pulmonary vasculitis
  • No known history of severe emphysema
  • No known history of pulmonary emboli
  • No other condition that causes pulmonary hypertension due to compromised pulmonary arterial vasculature
  • No known history of severe pulmonary hypertension (i.e., systolic pulmonary artery pressures > 90 mm Hg)
  • No known history of congenital heart defect that creates a bidirectional or right-to-left shunt
  • No worsening or clinically unstable congestive heart failure
  • No known acute myocardial infarction or acute coronary syndromes
  • No known serious ventricular arrhythmias
  • Not at high risk for arrhythmia due to prolongation of the QT interval
  • No known or suspected hypersensitivity to blood, blood products, or albumin
  • No known hypersensitivity to perflutren
  • No known or suspected hypersensitivity to octafluoropropane or any other ingredients of perflutren lipid microspheres (Definity®)
  • No mental status problems, illiteracy, or other circumstance that would preclude giving informed consent


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00626873

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Arthur Fleischer    615-322-2826      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Arthur Fleischer    615-322-2826      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Arthur C. Fleischer, MD Vanderbilt-Ingram Cancer Center
  More Information Identifier: NCT00626873     History of Changes
Other Study ID Numbers: CDR0000584233
Study First Received: February 28, 2008
Last Updated: August 11, 2009

Keywords provided by National Cancer Institute (NCI):
ovarian germ cell tumor
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders processed this record on March 24, 2017