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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Definity
* Other: medical chart review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definity<br>Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system. | Drug: Definity<br>* Definity - perflutren lipid microspheres, 1-10 microns in diameter, which is approved for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, to enhance the visualization of the ovarian vascular system.<br>* Other names: perflutren lipid microspheres;Other: medical chart review<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian microvascularity | To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian germ cell tumor, ovarian epithelial cancer