What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
|Uterine Bleeding Uterine Fibroids Adenomyosis||Procedure: Evaluation of MRI, US for pelvic and uterine conditions Procedure: Patient preference between MRI and Ultrasound||Early Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography|
- 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
- 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
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2019|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Procedure: Evaluation of MRI, US for pelvic and uterine conditions
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.
Active Comparator: 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.
Procedure: Patient preference between MRI and Ultrasound
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01992718
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Katherine Maturen, MD, MS||University of Michigan|