What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Bleeding, Uterine Fibroids, Adenomyosis

Intervention / Treatment
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* Procedure: Evaluation of MRI, US for pelvic and uterine conditions
* Procedure: Patient preference between MRI and Ultrasound


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evaluation of MRI, US for pelvic conditions<br>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. | Procedure: Evaluation of MRI, US for pelvic and uterine conditions<br>* Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®). A patient survey will be included.<br>|
| Active Comparator: Patient preference MRI vs. US<br>We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo. | Procedure: Patient preference between MRI and Ultrasound<br>* Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound. Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids | 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 | 1-2 months per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference between ultrasound and MRI | Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests | 6 months per patient |