Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Measure PAI/ultrasound signatures from ovaries prior to surgery
研究概览
简要总结
The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
- •Willingness to participate in the study
- •Able to provide informed consent
- •Exclusion Criteria
- •Younger than 18 years of age
- •Not able to provide informed consent
排除标准
- 未提供
研究组 & 干预措施
Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
- Transvaginal ultrasound (US) prior to surgery
- Immediately after the transvaginal US, US/PAI imaging will be performed
- Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis
干预措施: Transvaginal ultrasound (Device)
Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging
- Transvaginal ultrasound (US) prior to surgery
- Immediately after the transvaginal US, US/PAI imaging will be performed
- Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis
干预措施: Ultrasound/Photoacoustic imaging (Device)
结局指标
主要结局
Measure PAI/ultrasound signatures from ovaries prior to surgery
时间窗: Prior to surgery (no more than 30 days prior to surgery)
-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.
次要结局
- Characterize the tissue images with pathologic diagnosis(At the time of surgery (no more than 30 days after PAI/US))
- Refine the system and imaging algorithms based on the characteristic features of in vivo imaging(At the time of surgery (no more than 30 days after PAI/US))