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临床试验/NCT07280312
NCT07280312招募中不适用

Ultrasound Imaging of Ovarian and Adnexal Lesions

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月22日最近更新:
干预措施

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

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)

Experimental

Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.

干预措施: Transvaginal Ultrasound (Procedure)

Diagnostic (UMI, transvaginal ultrasound)

Experimental

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

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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