Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer
Overview
- Phase
- Phase 1
- Intervention
- Definity
- Conditions
- Ovarian Cancer
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 67
- Locations
- 3
- Primary Endpoint
- Ovarian microvascularity
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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-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.
Investigators
David Fishman
Professor Obstetrics, Gynecology and Reproductive Science, Director- Gynecologic Oncology Fellowship and National Ovarian Cancer Early Detection Program
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Definity
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.
Intervention: Definity
Definity
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.
Intervention: medical chart review
Outcomes
Primary Outcomes
Ovarian microvascularity
Time Frame: 2 years
To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.