What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Uterine Bleeding
- Sponsor
- University of Michigan
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 Description
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.
Investigators
Katherine Maturen, M.D.
Principal Investigator
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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 -
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Patient preference between ultrasound and MRI(6 months per patient)