Status:
COMPLETED
Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE1
Brief 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-enhan...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00626873
Start Date
January 1 2007
End Date
February 1 2012
Last Update
April 18 2017
Active Locations (3)
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1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
2
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838