Ultrasound Imaging of Ovarian and Adnexal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in O-RADS score
研究概览
简要总结
This clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are scheduled to have surgical treatment for their ovarian or adnexal lesions as part of their clinical care. Ovarian cancer is the most lethal gynecologic malignancy, often diagnosed at an advanced stage. Current diagnostic tools include a blood test (serum cancer antigen 125 [CA125]) and transvaginal ultrasound. However, CA125 has limited diagnostic accuracy and is Food and Drug Administration-approved only for monitoring the return of cancer (recurrence), not for preoperative diagnosis. A key measurement in calculating ovarian and adnexal cancer risk is by looking at increased blood flow, which may suggest a higher risk of cancer developing. However, current ultrasound techniques have limited ability to assess blood flow. A new ultrasound technique, UMI, may have higher sensitivity for detecting small blood vessels compared to traditional ultrasound imaging.
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
- •Female patients aged ≥ 18 years
- •Scheduled for surgery for ovarian or adnexal lesions
排除标准
- •Prior surgical removal of ovarian or adnexal lesions
- •Undergoing neoadjuvant chemotherapy or targeted systemic therapy
- •Vulnerable populations, including prisoners, adults lacking capacity to consent, and pregnant women (our study coordinator will ask participants if they are pregnant; if uncertain, a urine pregnancy test will be offered at no cost).
研究组 & 干预措施
Diagnostic (UMI, transvaginal ultrasound)
Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.
干预措施: Transvaginal Ultrasound (Procedure)
Diagnostic (UMI, transvaginal ultrasound)
Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.
干预措施: Ultrasound Microvessel Imaging (Procedure)
结局指标
主要结局
Change in O-RADS score
时间窗: Baseline
Ovarian-Adnexal Reporting and Data System (O-RADS) scores will be initially based on B-mode and Doppler imaging (standard of care) obtained prior to surgical treatment. Radiologists will then review ultrasound microvessel imaging (UMI) images and may choose to revise the score. Accuracy of score adjustments will be assessed using final pathology results from the participant's medical record.
次要结局
未报告次要终点
