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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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00626873
  Purpose

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
Procedure: medical chart review

MedlinePlus related topics: Cancer Ovarian Cancer Ultrasound
Drug Information available for: Octafluoropropane Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label
Official Title: Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

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

Primary Outcome Measures:
  • Ovarian microvascularity [ Designated as safety issue: No ]

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

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of adnexal mass
  • Scheduled to undergo surgical oophorectomy

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

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

Locations
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
Investigators
Study Chair: Arthur C. Fleischer, MD Vanderbilt-Ingram Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000584233, VU-VICC-GYN-0720, VU-VICC-061292
Study First Received: February 28, 2008
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00626873  
Health Authority: Unspecified

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

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009