Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
ovarian germ cell tumor, ovarian epithelial cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: perflutren lipid microspheres Type: Drug
Name: medical chart review Type: Other
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
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
Locations
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center - 800-811-8480
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Status: Recruiting
Contact: Arthur Fleischer - 615-322-2826
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Status: Recruiting
Contact: Arthur Fleischer - 615-322-2826
Start Date
January 2007
Sponsors
Vanderbilt-Ingram Cancer Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page