Clinical Trial: What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: University of Michigan

Current Primary Outcome: Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient preference between ultrasound and MRI [ Time Frame: 6 months per patient ]

Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: November 7, 2013
Date Started: November 2013
Date Completion: November 2019
Last Updated: November 2, 2016
Last Verified: November 2016