Microvascular Perfusion Sonographic Imaging to Detect Early Stage Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Ovarian microvascularity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Definity (Drug)
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.
干预措施: medical chart review (Other)
结局指标
主要结局
Ovarian microvascularity
时间窗: 2 years
To evaluate the use of contrast agents to depict the tumor microvascularity to detect ovarian cancer.
次要结局
未报告次要终点
研究者
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