What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
研究概览
简要总结
To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).
详细描述
Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
- •If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).
排除标准
- •If you are post-menopausal(have not had a period in at least one year's time).
- •If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
- •If you are unable or unwilling to sign the informed consents
- •If you are unable to undergo the research study exams -
研究组 & 干预措施
Evaluation of MRI, US for pelvic conditions
MRI and ultrasound imaging will be used clinically to evaluate pelvic pain and abnormal uterine bleeding. The goal is to determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluating patient preference.
干预措施: Evaluation of MRI, US for pelvic and uterine conditions (Procedure)
Patient preference MRI vs. US
We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.
干预措施: Patient preference between MRI and Ultrasound (Procedure)
结局指标
主要结局
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
时间窗: 1-2 months per patient
Arm 1 patients will undergo hysterectomy (per previously defined clinical decision unrelated to the study) 4-6 weeks after enrollment and imaging tests, allowing us to correlate imaging and pathologic findings
次要结局
- Patient preference between ultrasound and MRI(6 months per patient)
研究者
Katherine Maturen, M.D.
Principal Investigator
University of Michigan